Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria - 10/1/2004 -
(PDF),
(Text)
Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products - 9/23/2004 -
(PDF)
Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification - 8/20/2004 -
(PDF),
(Text)
Draft Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - 6/3/2004 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
(510(k)s) - 5/28/2004 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - 5/20/2004 -
(PDF),
(Text)
Draft Guidance for Industry: Combination Products, Timeliness of Premarket Reviews, Dispute Resolution - 5/4/2004 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices - 11/21/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications - 11/21/2003 - (PDF),
(Text)
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission - 11/21/2003 -
(PDF),
(Text)
- Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - 3/12/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review - 10/31/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - 10/8/2003
(Text),
(PDF)
Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification - 8/1/2003 -
(PDF),
(Text)
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003 -
(Text),
(PDF)
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices - 7/3/2003 - (PDF),
(Text)
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002 - Identification of Manufacturer of Medical Devices - 6/19/2003 -
(PDF),
(Text)
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review - 5/1/2003
(Text),
(PDF)
Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification - 3/12/2003 -
(PDF),
(Text)
