A petition is a way for individuals, regulated industry or consumer groups
to petition the agency to issue, change or cancel a regulation, or to take other
action. The agency receives about 200 petitions yearly.
| Docket # |
Petitioner |
Subject |
Date
Filed |
Date of
Interim Response(s) |
Completion of Petition |
| 94P-0268 |
MiniMed Technologies |
Implantable infusion pump for insulin |
7/15/94 |
3/21/03 |
|
| 01P-0298 |
Bio-Rad Laboratories |
Permit
mfrs. to allow the use of symbols in IVD labeling |
7/10/01 |
1/10/02
9/11/02
|
11/18/03 |
| 01P-0340 |
Association of Disposable Device Manufacturers |
Regulate
reprocessed single use as reusable medical devices |
8/15/01 |
2/11/02 |
|
| 01A-0375 |
PA Department of Health |
Collection
kits marketed by the Osborn Group, Inc. |
8/24/01 |
4/4/02 |
|
| 01P-0389 |
Kyper & Associates LLC |
To
revoke compliance program 7383.003 for class III 510(k) pre-amendment
devices |
9/5/01 |
|
3/13/03 |
| 02P-0089 |
St. Jude Medical |
Electronic
labeling programmer/computer that implanted pulse generator |
2/26/02 |
9/11/02 |
9/29/03 |
| 02P-0267 |
Nocona General Hospital |
To
amend the MQSA standard and FOI act to allow facilities to respond
and post responses to warning letters on the Internet. |
6/12/02 |
3/27/03 |
10/21/03 |
| 02P-0338 |
Russell J. Thomsen, M.D. |
Over-the-counter
sales for hand-held Doppler Fetoscopes |
7/29/02 |
1/24/03 |
6/19/03 |
| 02P-0437 |
Richard Strolworthy |
To
amend the FDA 510(k) policy to include disclosure & labeling requirements |
10/8/02 |
|
4/16/03 |
| 02P-0472 |
Zuckerman, Spaeder LLP |
To
post responses to warning letters on the Internet |
10/30/02 |
3/27/03 |
10/21/03 |
| 03P-0105 |
Mettler Electronics Corp. |
FDA
to revoke the medical device tracking order for invusion pumps |
3/14/03 |
|
5/28/03
|
| 03P-0166 |
Associated Pharmacologists & Toxicologists |
Revoke
approval for marketing of menstrual cups |
4/18/03 |
|
11/18/03 |
| 03P-0291 |
Tim Milburn, O.D. |
Contact
Lens |
6/24/03 |
|
|
| 03P-0297 |
Peter M. Rothenberg, MD, MA |
Exemption
for an accessory to an electrode cable |
6/30/03 |
|
8/14/03 |
| 03P-0362 |
Etymotic Research, Inc. |
Over-the-counter
Hearing Aids |
8/11/03 |
|
2/13/04 |
| 03P-0363 |
GudHear, Inc. |
Professional
and Patient Labeling for Hearing Aid Devices |
8/11/03 |
|
2/13/04 |
| 03P-0438 |
Russel J. Thomsen, M.D. |
Requesting FDA to reconsider decision on Over-the-counter
sales for hand-held doppler fetoscopes |
9/8/03 |
3/8/04 |
6/14/04 |
| 03P-0477 |
Endotec, Inc. |
Revoke
the AIP on Endotec |
10/10/03 |
3/26/04 |
|
| 03P-0511 |
National Organization for Women. |
Silicone
gel-filled breast implants |
11/3/03 |
|
11/17/03 |
| 03P-0530 |
Chemically Associated Neurological Disorders |
Silicone gel-filled breast implants.
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-A-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-B-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-L-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-M-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-O-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-P-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-T-vol1.pdf
|
11/18/03 |
|
12/4/03 |
| 03P-0555 |
Committee for Truth in Psychiatry |
Maintain
ECT in Class III |
12/10/03 |
|
|
| 04P-0003 |
Billy Pierson |
Med Watch complaint |
12/22/03 |
|
|
| 04P-0037 |
Etymotic Research Inc. |
TV-TIP
Sound Amplifier (WORD) |
1/22/04 |
|
|
| 04P-0055 |
BioRad |
Issue
a written opinion stating that unified, truthful labeling for domestic
and international sales is lawful |
2/6/04 |
|
|
| 04P-0091 |
Gastroparesis and Dysmotilities Association |
Transfer
Enterra Therapy from HUD to PMA |
2/26/04 |
|
|
| 04P-0164 |
Philips Medical Systems |
Exemption
from the medical devices tracking requirements for Heartstream automated
external defibrillators
|
4/6/04 |
|
|
| 04P-0276 |
Computerized Thermal Imaging Inc. |
Requesting
FDA to permit CTI to supplement the administrative record in connection
with CTI's PMA approval |
7/1/04 |
|
|
| 04P-0329 |
Russel J. Thomsen, M.D. |
Requesting FDA to hold a public hearings to consider
the appropriate regulatory status for low output, hand-held dopppler
fetoscopes.
|
7/26/04 |
|
|
| 04P-0334 |
Hyman, Phelps & McNamara, PC |
Requesting FDA torequire manufacturers of reprocessed
single-use electrosurgical cutting and coagulation devices and accessories
to submit validation data.
|
7/28/04 |
|
|
| 04P-0334 |
Hyman, Phelps & McNamara, PC |
Requesting
FDA torequire manufacturers of reprocessed single-use electrosurgical
cutting and coagulation devices and accessories to submit validation
data.
|
7/28/04 |
|
|
| 200P-0357 |
City of Arlington Texas |
Advisory
opinion regarding automatic eternal defibrillators |
8/9/04 |
|
|
| 200P-0357 |
City of Arlington Texas |
Advisory
opinion regarding automatic eternal defibrillators |
8/9/04 |
|
|
| 2004P-0368 |
Northwest Community Hospital |
FDA
to take action toward medical device manufacturers regarding the interchangeability
of medical devices with one another |
8/18/04 |
|
|
