On June 28, 2016, the FDA will hold a webinar for industry to review the Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act guidance document. 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.
We welcome your questions about this final guidance, so please mark your calendars to participate.
Webinar Details:
Registration is not necessary
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 hear the presentation and ask questions:
Dial: 888-324-2604; passcode: 2728146 | International callers dial: 1-630-395-0441
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW8727036p=2728146t=c
Conference Number: PW8727036
Following the conference, a transcript, audio recording and slides will be available at the Medical Device Webinars and Stakeholder Calls page.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.
Target Audience: Industry
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health