March 23, 2015
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
Comments of members of the Patient, Consumer, and Public Health Coalition on the draft guidance
“Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers”
[Docket No. FDA–2014-D-1837]
As members of the Patient, Consumer, and Public Health Coalition we support the draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device.
In 2012, the FDA began requiring that 510(k) numbers (premarket submission numbers) for cleared devices “be included with the device listing information.” This is important because many devices have the same name or very similar names and without a 510(k) number it is difficult or impossible to identify the exact device.
Now that device companies must provide the 510(k) number when they list their devices in the FDA’s Unified Registration and Listing System (FURLS), the FDA and other companies can quickly identify the owner of each 510(k) device. The Food, Drug & Cosmetics Act requires that the listing information be updated at least annually, and the guidance states that there can be only one 510(k) holder for a device at a time.
We suggest that Section V, part 2 of the draft guidance be modified. It states that if two people claim the same 510(k) number, the FDA “database will show the person who listed their device most recently until the issue is resolved.” To provide a more complete history of ownership, the database should list a timeline of 510(k) holders (owners), and this may help to eliminate any confusion over who currently holds the 510(k).
Members of the Patient, Consumer, and Public Health Coalition support this clear and concise draft guidance because the FDA “commonly receives notifications from individuals claiming that a 510(k)-clearance has been transferred to them.”1
American Medical Women’s Association
Breast Cancer Action
Center for Medical Consumers
Jacobs Institute of Women’s Health
Mothers Against Medical Error
National Center for Health Research
National Consumers League
National Women’s Health Network
The TMJ Association
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202)223-4000 or at firstname.lastname@example.org
 Food and Drug Administration (December 22, 2104). Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers (Draft Guidance). http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm427385.pdf
 Federal Register (December 22, 2014). Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers (Draft Guidance).