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  5. Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance on June 28, 2016
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance on June 28, 2016
June 27, 2016

Date:
June 27, 2016
Time:
08:00 PM - 08:00 PM EDT

        

Webinar Materials

On June 28, 2016, the FDA held 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.

Target Audience: Industry

If you have any questions regarding this guidance document, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health