On May 16, 2016, we issued the final guidance document Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act. Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance of certain class II or class III devices. This guidance document clarifies the 522 postmarket surveillance process and provides manufacturers with information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions.
The final guidance includes the following changes from the 2011 draft guidance:
- Incorporates modifications resulting from the amendments to section 522 under Section 616 of the Food and Drug Administration Safety Act (FDASIA), including specifying that a manufacturer must commence postmarket surveillance not later than 15 months after the day the order is issued. FDASIA also specified that the agency may issue a postmarket surveillance order at the time of device approval or clearance or any time thereafter.
- Clarifies the FDA’s recommendations for how manufacturers should request proposed changes to an approved surveillance plan and how the FDA will review such changes.
- Delineates the types of decision letters that the FDA may issue after reviewing proposed surveillance plans and supplements to approved surveillance plans.
- Specifies that the FDA may post on its website or otherwise make public interim summary data and/or FDA analysis when appropriate to protect the public health, as well as final report results.
- Adds a checklist to ensure the submissions are administratively complete.
FDA Webinar to discuss the Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act Final Guidance – June 28, 2016
On June 28, 2016, the FDA will hold a webinar for industry to discuss the recommendations in the Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act final guidance document. We welcome your questions about this final guidance, so please plan to participate. No registration is required.
Webinar Details:Date: June 28, 2016
Time: 1:00 -2:30 PM, Eastern Time.
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW8727036&p=2728146&t=c
Conference Number: PW8727036.
Following the webinar, written transcript, audio recording and slides will be available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or at [email protected].
Food and Drug Administration
Center for Devices and Radiological Health