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"Real-Time" Review Program for Premarket Approval Application (PMA) Supplements |
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ODE implemented a pilot of the "Real-Time" program for PMA supplements, which began in April 1996 as a pilot. Results of that pilot demonstrated that supplements reviewed in this format resulted in faster review times for manufacturers and efficient use of FDA staff time. Therefore, the "Real-Time" review process has been extended to all PMA Holders who wish to submit PMA supplements that meet the criteria outlined below.
Individual Branches and Divisions within ODE were permitted to develop criteria for the "Real-Time" review program. The content of those letters can be found below. The letters are arranged by Division and Branch. You can click on the appropriate highlighted organization in the table of contents below and you will be taken to the appropriate letter.
Real-Time review began on April 1, 1997 for devices covered by the Anesthesiology and Defibrillator Devices Group (ADDG) in the Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Ideal candidates for this program in the Anesthesiology and Defibrillator Devices Group include the following:
Implantable minor modifications to software resulting from performance/safety issues that Cardioverter place patients at high risk:
Other changes not listed here may be candidates for this
program. A call to the ADDG Group Leader will help you determine
if your proposed supplement qualifies. Supplements with detailed
clinical data, except for breakthrough technology mentioned
above, will generally not be considered for this program due to
the complexity of reviewing such data. Manufacturing site changes
will also not be considered since they are reviewed by the Office
of Compliance.
To participate in the "Real-Time" program, please do
the following:
At least THREE WEEKS prior to your actual supplement submission, send a fax to the attention of Richard N. Phillips, Ph.D., ADDG Group Leader, (301) 480-4204, and include a one-page description of the device, any expected issues, the estimated date we can expect your submission, and the following:
a) PMA Contact information including your address and phone number
b) PMA document number
c) Reason(s) for submission - a brief description of the proposed change and the reason for the change
d) An outline of all information, including any testing performed, which is intended to substantiate the change
e) Manufacturing site name(s) and addresses
f) Specify whether we have seen this type of change in a previous submission, identify the device for which the change was approved, and provide the PMA/supplement number.
The PMA supplement must be received by the ADDG at least THREE WEEKS before a meeting or conference call can be scheduled. The ADDG will notify you within 5 DAYS after receiving the supplement in the Group if it will be officially accepted as a "Real-Time" supplement. ADDG staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
- FDA/CDRH/ODE
- Attention: (Division contact) HFZ-450
- 9200 Corporate Blvd.
- Rockville, MD 20850
CDRH attendees at any meeting or conference call will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. FDA review will be conducted during the meeting, with data presentation by you and scientific discussion of the issues. A letter with an approval, approvable, or not approvable decision will be faxed to you within ONE TO FIVE WORKING DAYS after the meeting or call, with the hard copy to follow.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is important that you provide a clear, well organized, and complete PMA supplement. The supplement should contain a detailed description of the proposed change, a complete assessment of the impact of the change on the safety and effectiveness of the device, and a summary of the data from testing which is intended to support the change and demonstrate a reasonable assurance of safety and effectiveness. Use of graphical representation of data, illustrations, pagination and use of tabs are recommended to more effectively communicate the changes being made. This amount of detail also applies if a meeting or conference call is scheduled.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter, or believe your current or planned supplements fit this program, you are encouraged to contact Richard N. Phillips, Ph.D. at (301) 443-8609.
Real-Time review began on April 1, 1997 for devices covered by the Circulatory Support and Prosthetic Devices Group (CSPG) in the Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Ideal candidates for this program in the Circulatory Support and Prosthetic Devices Group include the following:
Other changes not listed here may be candidates for this program. A call to the CSPG Group Leader will help you determine if your proposed supplement qualifies. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data. Manufacturing site changes will also not be considered since they are reviewed by the Office of Compliance.
To participate in the "Real-Time" program, please do the following:
a) PMA Contact information including your address and phone number
b) PMA document number
c) Reason(s) for submission - the proposed changes and the reason for the change
d) An outline of all information, including any testing performed, which is intended to substantiate the change
e) Manufacturing site name(s) and addresses
f) Specify whether we have seen this type of change in a previous submission, identify the device for which the change was approved, and provide the PMA/supplement number.
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
- FDA/CDRH/ODE
- Attention: (Division contact) HFZ-450
- 9200 Corporate Blvd.
- Rockville, MD 20850
CDRH attendees at any meeting or conference call will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. FDA review will be conducted during the meeting, with data presentation by you and scientific discussion of the issues. A letter with an approval, approvable, or not approvable decision will be faxed to you within ONE TO FIVE WORKING DAYS after the meeting or call, with the hard copy to follow.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is important that you provide a clear, well organized, and complete PMA supplement. The supplement should contain a detailed description of the proposed change, a complete assessment of the impact of the change on the safety and effectiveness of the device, and a summary of the data from testing which is intended to support the change and demonstrate a reasonable assurance of safety and effectiveness. Use of graphical representation of data, illustrations, pagination and use of tabs are recommended to more effectively communicate the changes being made. This amount of detail also applies if a meeting or conference call is scheduled.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter, or believe your current or planned supplements fit this program, you are encouraged to contact Bette Lemperle at (301) 443-8262.
Real-Time review began on April 1, 1997 for devices covered by the Interventional Cardiology Devices Group (ICDG) in the Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Ideal candidates for this program in the Interventional Cardiology Devices Group include the following:
PTCA Catheters:
Pacing Leads
All ICDG Devices
Other changes not listed here may be candidates for this program. A call to the ICDG Group Leader will help you determine if your proposed supplement qualifies. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data. Manufacturing site changes will also not be considered since they are reviewed by the Office of Compliance.
To participate in the "Real-Time" program, please do the following:
a) PMA Contact information including your address and phone number
b) PMA document number
c) Reason(s) for submission - the proposed changes and reason for the change
d) An outline of all information, including any testing performed, which is intended to substantiate the change
e) Manufacturing site name(s) and addresses
f) Specify whether we have seen this type of change in a previous submission, identify the device for which the change was approved, and provide the PMA/supplement number.
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
- FDA/CDRH/ODE
- Attention:(Division contact) HFZ-450
- 9200 Corporate Blvd.
- Rockville, MD 20850
CDRH attendees at any meeting or conference call will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. FDA review will be conducted during the meeting, with data presentation by you and scientific discussion of the issues. A letter with an approval, approvable, or not approvable decision will be faxed to you within ONE TO FIVE WORKING DAYS after the meeting or call, with the hard copy to follow.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is important that you provide a clear, well organized, and complete PMA supplement. The supplement should contain a detailed description of the proposed change, a complete assessment of the impact of the change on the safety and effectiveness of the device, and a summary of the data from testing which is intended to support the change and demonstrate a reasonable assurance of safety and effectiveness. Use of graphical representation of data, illustrations, pagination and use of tabs are recommended to more effectively communicate the changes being made. This amount of detail also applies if a meeting or conference call is scheduled.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter, or believe your current or planned supplements fit this program, you are encouraged to contact Tara Ryan at (301) 443-8243.
Real-Time review began on April 1, 1997 for devices covered by the Pacing and Neurological Devices Group (PNDG) in the Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Ideal candidates for this program in the Pacing and Neurological Devices Group include the following:
All Pacing and low risk changes which do not affect or impact the primary function or Neurological performance of the device:
Other changes not listed here may be candidates for this program. A call to the PNDG Group Leader will help you determine if your proposed supplement qualifies. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data. Manufacturing site changes will also not be considered since they are reviewed by the Office of Compliance.
To participate in the "Real-Time" program, please do the following:
a) PMA Contact information including your address and phone number
b) PMA document number
c) Reason(s) for submission - the proposed changes and reason for the change
d) An outline of all information, including any testing performed, which is intended to substantiate the change
e) Manufacturing site name(s) and addresses
f) Specify whether we have seen this type of change in a previous submission, identify the device for which the change was approved, and provide the PMA/supplement number.
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
In addition, when requested, any identical extra copies required for PNDG team review should be clearly bolded - REAL TIME REVIEW EXTRA COPIES. Be sure to include the name of the PNDG contact person. The address for extra copies is:
- FDA/CDRH/ODE
- Attention: (Division contact) HFZ-450
- 9200 Corporate Blvd.
- Rockville, MD 20850
CDRH attendees at any meeting or conference call will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. FDA review will be conducted during the meeting, with data presentation by you and scientific discussion of the issues. A letter with an approval, approvable, or not approvable decision will be faxed to you within ONE TO FIVE WORKING DAYS after the meeting or call, with the hard copy to follow.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is important that you provide a clear, well organized, and complete PMA supplement. The supplement should contain a detailed description of the proposed change, a complete assessment of the impact of the change on the safety and effectiveness of the device, and a summary of the data from testing which is intended to support the change and demonstrate a reasonable assurance of safety and effectiveness. Use of graphical representation of data, illustrations, pagination and use of tabs are recommended to more effectively communicate the changes being made. This amount of detail also applies if a meeting or conference call is scheduled.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter, or believe your current or planned supplements fit this program, you are encouraged to contact the Interim Group Leader at (301) 443-8517.
This pilot began on March 24, 1997.
Manufacturing site changes will not be included in this program. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data.
Ideal candidates for this program would include the following:
DCLD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" pilot program, please do the following:
Fax an agenda which contains the following:
a) PMA Contact information including applicant address and phone number
b) PMA document number
C) Reason(s) for submission
d) Outline of device issues
e) Specify face-to-face meeting, teleconference, or video-conference
f) Timeframe for submission
g) Proposed meeting date(s)
h) Manufacturing site name(s) and addresses
If your supplement has already been submitted for review and you would like it considered for "Real-Time" review, please contact me.
To submit a real time supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW. In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded REAL TIME REVIEW EXTRA COPIES and also be sure to include my name as your Division contact person.
The address for extra copies is:
- FDA/CDRH/ODE
- Attention: Dr. Joseph L. Hackett HFZ-440
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the division at least TWO WORKING DAYS before the scheduled meeting. otherwise, the meeting will be canceled and the supplements may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
The planned format of a "Real-Time" review meeting is as follows:
FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will be no more than five working days.
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via a facsimile within one to five working days, with the hard copy to follow. applicants who believe their current or planned supplements fit this expanded pilot program are encouraged to call and, if the DCLD staff concurs, schedule a date for "Real-Time" review.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is in the interest of the applicant to provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this pilot.
If you have any questions regarding this letter or the "Real-Time" pilot program, then please contact Joseph L. Hackett, Ph.D. at (301) 594-3084.
This program began on April 7, 1997 for devices reviewed by the Division of Dental, Infection Control and General Hospital Devices (DDIGD).
Applicants who believe their current or planned supplemental submission is appropriate for this program are encouraged to call, and if the DDIGD staff concurs, schedule a date for a "Real-Time" review. The review will be conducted during the meeting or teleconference with data presentation by the applicant and a scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed to the applicant will commonly be the next working day and no more than (5) working days for more complicated situations.
Ideal candidates for this program would include the following:
Supplements that are closely related to previously submitted supplements should be identified, but for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track supplements will not be included in this program, nor will supplements with detailed preclinical or clinical data be considered for this program due to the complexity of reviewing such data.
The DDIGD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" program, please do the following:
OR
1. Authorized contact person information including name, address and phone number
2. PMA document number (e.g. P970001)
3. Specify if you prefer a meeting, video-conference, or tele-conference
4. Manufacturing site name(s) and addresses
5. If your supplement has previously been submitted for review and you would like it considered for "Real-Time" review, please contact the appropriate Branch Chief listed above.
To submit a "Real-Time" supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW. In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded - REAL TIME REVIEW EXTRA COPIES and also be sure to include the name of your Division contact person. The address for extra copies is:
- FDA/CDRH/ODE
- Attention: (Division contact) HFZ-480
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the Division at least TWO WORKING DAYS before the scheduled meeting. Otherwise, the meeting will be canceled and the supplements may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
A major portion of the FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via a facsimile within one to five working days, with the hard copy to follow. applicants who believe their current or planned supplements fit this expanded pilot program are encouraged to call and, if the DDIGD staff concurs, schedule a date for "Real-Time" review.
Since the ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, the applicant must provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of the relevant PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter or the "Real-Time" program, then please contact Ms. Patricia Cricenti, Acting Branch Chief, GHDB at(301) 594-1287, Dr. Susan Runner, Branch Chief, DEDB at (301) 827-5283 and Dr. Chiu Lin, INCB at (301) 443-8913.
Due to the initial successes of the "Real-Time" pilot program for PMA supplements in the Orthopedic Devices Branch (ORDB) and the Plastic and Reconstructive Surgery Devices Branch (PRSB) within the Division of General and Restorative Devices (DGRD), the pilot was expanded to include the Restorative Devices Branch (REDB) and the General Surgery Devices Branch (GSDB). This expanded program began on March 10, 1997. The information provided below incorporates the original pilot information and updated information for ORDB and PRSB.
Manufacturing site changes will not be included in this program. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data.
Ideal candidates for this program would include the following:
DGRD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" pilot program, please do the following:
a) PMA Contact information including applicant address and phone number
b) PMA document number
c) Reason(s) for submission
d) Specify face-to-face meeting, tele-conference, or video-conference
e) Timeframe for submission
f) Proposed meeting date(s)
g) Manufacturing site name(s) and addresses
To submit a real time supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center HFZ-401
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW.
In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded - REAL TIME REVIEW EXTRA COPIES and also be sure to include the name of your Division contact person.
The address for extra copies is:
- FDA/CDRH/ODE
- Attention: (Division contact) HFZ-410
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the division at least TWO WORKING DAYS before the scheduled meeting. Otherwise, the meeting will be cancelled and the supplements may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
The planned format of a "Real-Time" review meeting is as follows:
FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will be no more than five (5) working days.
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via a facsimile within one to five working days, with the hard copy to follow.
applicants who believe their current or planned supplements fit this expanded pilot program are encouraged to call and, if the DGRD staff concurs, schedule a date for "Real-Time" review.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is in the interest of the applicant to provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this pilot.
If you have any questions regarding this letter or the "Real-Time" pilot program, then please contact Captain Marie Schroeder at (301) 594-1296 for restorative devices, Dr. George Jan at (301) 594-1307 for general surgery devices, Mr. Mark Melkerson at (301) 594-2090 for orthopedic devices, or Mr. Stephen Rhodes, at (301) 594-3090 for plastic and reconstructive devices..
The Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) is implementing a "Real-Time" review program for PMA supplements. This program will begin on June 1, 1997 for devices covered by the Diagnostic and Surgical Devices Branch (DSDB) of the Division of Ophthalmic Devices (DOD).
The devices include lasers for refractive surgery and Nd:YAG lasers for ophthlamic uses other than posterior capsulotomy, as well as all other devices reviewed under PMA.
Manufacturing site changes will not be included in this program. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data.
Ideal candidates for this program would include the following:
DOD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" program, please do the following:
a. PMA contact information including applicant address and phone number
b. PMA document number
c. Reason(s) for submission
d. Specify face-to-face meeting, teleconference, or video-conference
e. Time frame for submission
f. Proposed meeting date(s)
g. Manufacturing site name(s) and addresses
If your supplement has already been submitted for review and you would like it considered for "Real-Time" review, please contact Ms. Falls.
To submit a real time supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center (HFZ-401)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW. In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded - REAL TIME REVIEW EXTRA COPIES and sent to Ms. Deborah Falls.
The address for extra copies is:
- FDA/CDRH/ODE
- Attention: Ms. Deborah Falls (HFZ-460)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the division at least TWO WORKING DAYS before the scheduled meeting. Otherwise, the meeting will be canceled and the supplement may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
The planned format of a "Real-Time" review meeting is as follows:
FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will be no more than five working days.
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via fax within one to five working days, with the hard copy to follow. Applicants who believe their current or planned supplements fit this "Real-Time" review program are encouraged to call and, if the DOD staff concurs, schedule a date for "Real-Time" review.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is in the interest of the applicant to provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter or the "Real-Time" program, please contact Ms. Deborah Falls at (301) 594-2205 or Morris Waxler, Ph.D. at (301) 594-2018.
The Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) is implementing a "Real-Time" review program for PMA supplements. This program will begin on April 30, 1997 for devices covered by the Intraocular and Corneal Implants Branch (ICIB) of the Division of Ophthalmic Devices (DOD).
The devices include intraocular lenses and viscoelastics, as well as all other devices reviewed under PMA.
Manufacturing site changes will not be included in this program. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data.
Ideal candidates for this program would include the following:
DOD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" program, please do the following:
a. PMA contact information including applicant address and phone number
b. PMA document number
c. Reason(s) for submission
d. Specify face-to-face meeting, teleconference, or video-conference
e. Time frame for submission
f. Proposed meeting date(s)
g. Manufacturing site name(s) and addresses
If your supplement has already been submitted for review and you would like it considered for "Real-Time" review, please contact Ms. Falls.
To submit a real time supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center (HFZ-401)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW. In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded - REAL TIME REVIEW EXTRA COPIES and sent to Ms. Deborah Falls.
The address for extra copies is:
- FDA/CDRH/ODE
- Attention: Ms. Deborah Falls (HFZ-460)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the division at least TWO WORKING DAYS before the scheduled meeting. Otherwise, the meeting will be canceled and the supplement may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
The planned format of a "Real-Time" review meeting is as follows:
FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will be no more than five working days.
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via fax within one to five working days, with the hard copy to follow. Applicants who believe their current or planned supplements fit this "Real-Time" review program are encouraged to call and, if the DOD staff concurs, schedule a date for "Real-Time" review.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is in the interest of the applicant to provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this program.
If you have any questions regarding this letter or the "Real-Time" program, please contact Ms. Deborah Falls at (301) 594-2205 or Ms. Donna Lochner at (301) 594-2053.
The Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), is expanding the real-time review pilot to medical devices covered by the Vitreoretinal & Extraocular Devices Branch (VEDB) of the Division of Ophthalmic Devices (DOD). This expanded pilot will begin on March 17, 1997.
The devices include extended wear contact lenses, intraocular gases and intraocular fluids used for vitreoretinal surgery such as silicone oil. The "Real Time" pilot program will also include PMA supplements for contact lens care products until the reclassification of these devices from Class III to Class II takes effect.
Manufacturing site changes will not be included in this program. Supplements with detailed clinical data will generally not be considered for this program due to the complexity of reviewing such data.
Ideal candidates for this program would include the following:
DOD staff reserves the option to refuse supplements for the program if there are concerns about the ability to perform an effective review in the "Real-Time" format.
To participate in the "Real-Time" pilot program, please do the following:
a.) PMA contact information including applicant address and phone number
b.) PMA document number
c.) Reason(s) for submission
d.) Specify face-to-face meeting, tele-conference, or video-conference
e.) Time frame for submission
f.) Proposed meeting date(s)
g.) Manufacturing site name(s) and addresses
If your supplement has already been submitted for review and you would like it considered for "Real-Time" review, please contact Ms. Falls.
To submit a real time supplement, please send an original and two copies to:
- FDA/CDRH/ODE
- Document Mail Center (HFZ-401)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement needs to include a cover letter header bolded - REAL TIME REVIEW. In addition, the Division may need to negotiate extra copies (beyond the three required by regulation). Any identical extra copies should be clearly bolded - REAL TIME REVIEW EXTRA COPIES and sent to Ms. Deborah Falls.
The address for extra copies is:
- FDA/CDRH/ODE
- Attention: Ms. Deborah Falls (HFZ-460)
- 9200 Corporate Blvd.
- Rockville, MD 20850
The PMA supplement must be received by the division at least TWO WORKING DAYS before the scheduled meeting. Otherwise, the meeting will be canceled and the supplement may then be reviewed under the standard time frames if a meeting, video conference, or telephone conference cannot be conveniently rescheduled.
The planned format of a "Real-Time" review meeting is as follows:
FDA review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will be no more than 5 working days.
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A letter with an approval, approvable, or not approvable decision will be sent via fax within 1 to 5 working days, with the hard copy to follow. Applicants who believe their current or planned supplements fit this expanded pilot program are encouraged to call and, if the DOD staff concurs, schedule a date for "Real-Time" review.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information and data presented, it is in the interest of the applicant to provide a clear, well-organized, and complete presentation and PMA supplement.
CDRH anticipates continued mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect this program to delay review times for other types of documents. The Center will continue to assess the success of this pilot.
If you have any questions regarding this letter or the "Real-Time" pilot program, please contact Ms. Deborah Falls at (301) 594-2205 or James Saviola, O.D. at (301) 594-1744.
The Center for Devices and Radiological Health (CDRH) would like to announce expansion of the "Real-Time" Review Pilot Program to the Radiology Devices Branch (RADB) of the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices (DRAERD) within the Office of Device Evaluation (ODE). This pilot program is for some types of supplemental Premarket Approval Applications (PMA).
The pilot began in RADB on December 1, 1996, and the results will be evaluated periodically to determine the success of this pilot program. Applicants who believe their current or planned supplemental submission is appropriate for this pilot are encouraged to call DRAERD and if the agency's staff concurs, schedule a date for "Real-Time" review. Review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will commonly be the next working day and no more than five (5) working days for more complicated situations.
Ideal candidates for this pilot program would include the following:
- Sterilization changes to another known method
- Similar PMA supplements previously submitted (e.g., minor design changes)
- Material changes to another known material
- Minor labeling changes
applicants are encouraged to submit related supplements simultaneously. Supplements which are closely related to supplements submitted previously should be identified but, for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track PMA supplements will not be included in this pilot program. The complexity of reviewing clinical data precludes incorporating panel track supplements in this pilot.
DRAERD reserves the option to refuse supplements for the pilot program if there are concerns about the ability to perform an effective review in this format.
How to get your supplement into the "Real-Time" Pilot:
- Fax your estimated date of submitting the supplement with a one page description of the device and expected issues to Robert A. Phillips, Ph.D., Branch Chief, RADB, (301) 480-4224 (fax).
- Two weeks before submission call or fax a request to schedule a meeting or video supported teleconference. Fax an agenda for the meeting, an outline of the device issues, manufacturing site locations, contact=s name and phone number, and a list of attendees. Please do not submit a copy of the submission at this time.
- If your supplement has previously been submitted for review and your company would like it considered for this pilot, please call Dr. Phillips.
Note, at least three copies of the PMA supplement must be brought with you at the day of the meeting to be logged into the Document Mail Center. For video supported teleconferences and conference calls, the submission must be received in the division at least two working days before the scheduled conference. Otherwise, the conference will be cancelled and rescheduled for a later date.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information presented, it is in the best interest of the applicant to provide a clear, well organized and complete presentation and supplement application.
The format of the review meeting will be as follows:
- Brief presentation by applicant
- Discussion
- Breakout into scientific discipline groups, if appropriate
- CDRH break for discussion
- Same day CDRH verbal feedback to applicant
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A decision letter of Approval, Approvable, or a Not Approvable will be sent via facsimile within one to five working days, followed by a hard copy.
CDRH anticipates mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect the pilot to delay review times for other types of documents.
If you have any questions, regarding supplements you have already submitted or plan to submit, please contact Robert A. Phillips, Ph.D. at (301) 594-1212.
The Center for Devices and Radiological Health (CDRH) would like to announce expansion of the "Real-Time" Review Pilot Program to the Ear, Nose, and Throat Devices Branch (ENTB) of the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices (DRAERD) within the Office of Device Evaluation (ODE). This pilot is for some types of Premarket Approval Application (PMA) supplements.
The purpose of this pilot is to assess the possibility of conducting document reviews in "Real Time" in a meeting or teleconference format. Expected benefits include rapid review times for manufacturers and efficient use of FDA staff time.
The pilot will begin in ENTB on November 1, 1996, and the results will be evaluated periodically to determine the success of this pilot program. Applicants who believe their current or planned supplemental submission is appropriate for this pilot are encouraged to call DRAERD and if the agency's staff concurs, schedule a date for "Real-Time" review. Review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will commonly be the next working day and no more than five (5) working days for more complicated situations.
Ideal candidates for this pilot would include the following:
sterilization changes to another known method
similar PMA supplements previously submitted (e.g., minor design changes)
material changes to another known material
minor labeling changes
applicants are encouraged to submit related supplements simultaneously. Supplements which are closely related to supplements submitted previously should be identified but, for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track PMA supplements will not be included in this pilot program. The complexity of reviewing clinical data precludes incorporating panel track supplements in this pilot.
DRAERD reserves the option to refuse supplements for the pilot program if there are concerns about the ability to perform an effective review in this format.
How to get your supplement into the "Real-Time" Pilot:
Fax your estimated date of submitting the supplement with a one-page description of the device and expected issues to Harry R. Sauberman, Branch Chief, ENTB, 301-480-4224 (fax).
Two weeks before submission call or fax a request to schedule a meeting or video supported teleconference. Fax an agenda for the meeting, an outline of the device issues, manufacturing site locations, contact's name and phone number, and a list of attendees. Please do not submit a copy of the submission at this time.
If your supplement has previously been submitted for review and your company would like it considered for this pilot, please call Mr. Sauberman.
Note, at least three copies of the PMA supplement must be brought with you at the day of the meeting to be logged into the Document Mail Center. For video supported teleconferences and conference calls, the submission must be received in the division at least two working days before the scheduled conference. Otherwise, the conference will be canceled and rescheduled for a later date.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information presented, it is in the interest of the applicant to provide a clear, well-organized and complete presentation and supplement application.
The format of the review meeting will be as follows:
brief presentation by applicant
discussion
breakout into scientific discipline groups, if appropriate
CDRH break for discussion
same day CDRH verbal feedback to applicant
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A decision letter of an Approval, Approvable, or a Not Approvable will be sent via facsimile within one to five working days, followed by a hard copy.
CDRH anticipates mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect the pilot to delay review times for other types of documents.
If you have any questions regarding supplements you have already submitted or plan to submit, please contact Mr. Sauberman 594-2080.
The pilot began in GRDB on March 15, 1997, and the results will be evaluated periodically to determine the success of this pilot program. Applicants who believe their current or planned supplemental submission is appropriate for this pilot are encouraged to call DRAERD and if the agency's staff concurs, schedule a date for "Real-Time" review. Review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is FAXed will commonly be the next working day and no more than 5 working days for more complicated situations.
Ideal candidates for this pilot would include the following:
applicants are encouraged to submit related supplements simultaneously. Supplements which are closely related to supplements submitted previously should be identified but, for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track PMA supplements will not be included in this pilot program. The complexity of reviewing clinical data precludes incorporating panel track supplements in this pilot.
DRAERD reserves the option to refuse supplements for the pilot program if there are concerns about the ability to perform an effective review in this format.
How to get your supplement into the "Real-Time" Pilot:
Approximately 2 weeks before submission, call or FAX a request to schedule a meeting or video supported teleconference. Please include proposed meeting dates and times. FAX an agenda for the meeting, an outline of the device issues, manufacturing site names and locations, PMA number, the name of the firm's contact person and phone number, and a list of attendees. Please do not submit a copy of the submission at this time.
If your supplement has previously been submitted for review and your company would like it considered for this pilot, please call Dr. Neuland at (301)594-1220.
Note, at least three copies of the PMA supplement must be brought with you at the day of the meeting to be logged into the Document Mail Center. For video supported teleconferences and conference calls, the submission must be received in the division at least 2 working days before the scheduled conference. Otherwise, the conference will be canceled and rescheduled for a later date. Please include in your PMA supplement cover letter a reference section with the following phrase (in bold letters) - ACCEPTED FOR REAL TIME REVIEW. Our Document Mail Center hours for document receipt are 8 a.m. to 4:30 p.m. Please send all correspondence to the following address:
- PMA Document Mail Center (HFZ-401)
- Center for Devices and Radiological Health
- Food and Drug Administration
- 9200 Corporate Blvd.
- Rockville, Maryland 20850
Since our ability to make "Real-Time" review decisions will depend on the quality of the information presented, it is in the interest of the applicant to provide a clear, well-organized and complete presentation and supplement application. Please be aware that extra copies of PMA supplements may be requested to enhance and expedite the review process.
The format of the review meeting will be as follows:
CDRH attendees will be selected based on the device issues anticipated from the pre-submission FAXes and phone call(s) from the applicant. A decision letter of an Approval, Approvable, or Not Approvable will be sent via facsimile within 1 to 5 working days, followed by a hard copy.
CDRH anticipates mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect the pilot to delay review times for other types of documents.
If you have any questions regarding supplements you have already submitted or plan to submit, please contact Dr. Neuland at (301)594-1220.
The pilot began in OGDB on March 15, 1997, and the results will be evaluated periodically to determine the success of this pilot program. Applicants who believe their current or planned supplemental submission is appropriate for this pilot are encouraged to call DRAERD and if the agency's staff concurs, schedule a date for "Real-Time" review. Review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is FAXed will commonly be the next working day and no more than 5 working days for more complicated situations.
Ideal candidates for this pilot would include the following:
applicants are encouraged to submit related supplements simultaneously. Supplements which are closely related to supplements submitted previously should be identified but, for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track PMA supplements will not be included in this pilot program. The complexity of reviewing clinical data precludes incorporating panel track supplements in this pilot.
DRAERD reserves the option to refuse supplements for the pilot program if there are concerns about the ability to perform an effective review in this format.
How to get your supplement into the "Real-Time" Pilot:
Approximately 2 weeks before submission, call or FAX a request to schedule a meeting or video supported teleconference and:
Please do not submit a copy of the submission at this time.
If your supplement has previously been submitted for review and your company would like it considered for this pilot, please call Mr. Pollard at 301-594-1180.
Note, at least three copies of the PMA supplement must be brought with you at the day of the meeting to be logged into the Document Mail Center. For video supported teleconferences and conference calls, the submission must be received in the division at least 2 working days before the scheduled conference. Otherwise, the conference will be canceled and rescheduled for a later date. Please include in your PMA supplement cover letter a reference section with the following phrase (in bold letters) - ACCEPTED FOR REAL TIME REVIEW. Our Document Mail Center hours for document receipt are 8 a.m. to 4:30 p.m. Please send all correspondence to the following address:
- PMA Document Mail Center (HFZ-401)
- Center for Devices and Radiological Health
- Food and Drug Administration
- 9200 Corporate Blvd.
- Rockville, Maryland 20850
Since our ability to make "Real-Time" review decisions will depend on the quality of the information presented, it is in the interest of the applicant to provide a clear, well-organized and complete presentation and supplement application. Please be aware that extra copies of PMA supplements may be requested to enhance and expedite the review process.
The format of the review meeting will be as follows:
CDRH attendees will be selected based on the device issues anticipated from the pre-submission FAXes and phone call(s) from the applicant. A decision letter of an Approval, Approvable, or Not Approvable will be sent via facsimile within 1 to 5 working days, followed by a hard copy.
CDRH anticipates mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect the pilot to delay review times for other types of documents.
If you have any questions regarding supplements you have already submitted or plan to submit, please contact Mr. Pollard at 301-594-1180.
The Center for Devices and Radiological Health (CDRH) would like to announce expansion of the "Real-Time" Review Pilot Program to the Urology and Lithotripsy Devices Branch (ULDB) of the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices (DRAERD) within the Office of Device Evaluation (ODE). This pilot is for some types of Premarket Approval Application (PMA) supplements.
The purpose of this pilot is to assess the possibility of conducting document reviews in "Real Time" in a meeting or teleconference format. Expected benefits include rapid review times for manufacturers and efficient use of FDA staff time.
The pilot will begin in ULDB on October 1, 1996, and the results will be evaluated periodically to determine the success of this pilot program. Applicants who believe their current or planned supplemental submission is appropriate for this pilot are encouraged to call DRAERD and if the agency's staff concurs, schedule a date for "Real-Time" review. Review will be conducted during the meeting, with data presentation by the applicant and scientific discussion of the issues. The anticipated time from the close of the review meeting until the action letter is faxed will commonly be the next working day and no more than five (5) working days for more complicated situations.
Ideal candidates for this pilot would include the following:
Sterilization changes to another known method
Similar PMA supplements previously submitted (e.g., minor design changes)
Material changes to another known material
Minor labeling changes
applicants are encouraged to submit related supplements simultaneously. Supplements which are closely related to supplements submitted previously should be identified but, for reviewing purposes, kept as separate supplements. Manufacturing site changes and panel track PMA supplements will not be included in this pilot program. The complexity of reviewing clinical data precludes incorporating panel track supplements in this pilot.
DRAERD reserves the option to refuse supplements for the pilot program if there are concerns about the ability to perform an effective review in this format.
How to get your supplement into the "Real-Time" Pilot:
Fax your estimated date of submitting the supplement with a one-page description of the device and expected issues to Donald St.Pierre, Branch Chief, ULDB, 301-594-2339 (fax).
Two weeks before submission call or fax a request to schedule a meeting or video supported teleconference. Fax an agenda for the meeting, an outline of the device issues, manufacturing site locations, contact's name and phone number, and a list of attendees. Please do not submit a copy of the submission at this time.
If your supplement has previously been submitted for review and your company would like it considered for this pilot, please call Mr. St.Pierre.
Note, at least three copies of the PMA supplement must be brought with you at the day of the meeting to be logged into the Document Mail Center. For video supported teleconferences and conference calls, the submission must be received in the division at least two working days before the scheduled conference. Otherwise, the conference will be canceled and rescheduled for a later date.
Since our ability to make "Real-Time" review decisions will depend on the quality of the information presented, it is in the interest of the applicant to provide a clear, well-organized and complete presentation and supplement application.
The format of the review meeting will be as follows:
Brief presentation by applicant
Discussion
Breakout into scientific discipline groups, if appropriate
CDRH break for discussion
Same day CDRH verbal feedback to applicant
CDRH attendees will be selected based on the device issues anticipated from the pre-submission faxes and phone call(s) from the applicant. A decision letter of an Approval, Approvable, or a Not Approvable will be sent via facsimile within one to five working days, followed by a hard copy.
CDRH anticipates mutual benefit in terms of greatly reduced time from receipt until approval of PMA supplements. We do not expect the pilot to delay review times for other types of documents.
If you have any questions regarding supplements you have already submitted or plan to submit, please contact Mr. St.Pierre at 594-2194.
Updated April 22, 1997
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