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  5. Webinar – Final Guidances on Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act - 12/06/2022
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar – Final Guidances on Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act
December 6, 2022

Date:
December 6, 2022
Time:
1:00 PM - 2:00 PM ET

Summary

On December 6, 1-2:00 p.m. ET, the U.S. Food and Drug Administration (FDA) held a webinar for stakeholders to learn more about the two final guidances that are intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These guidances are also intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and PAS requirements.

During this webinar the FDA discussed:

  • Purpose and scope of the updated PAS and 522 guidance documents.
  • Recommendations concerning the format, content, and review of submissions.
  • Recommendations to help facilitate the FDA’s review of a PAS protocol and 522 plan in a timely manner.
  • Revised FDA review time goals for submissions.
  • Recommendations for study timelines including enrollment milestones and study completion.
  • Updated status categories that better reflect progress of the study.
  • FDA’s approach to increase transparency to stakeholders on PAS and 522 studies.

Background

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), will host a public webinar to share information and answer questions about the two final guidances Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order and Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. During this webinar, the FDA will provide highlights of the two final guidances and answer questions from webinar attendees.

Webinar Details

Registration is not necessary to attend.

Date: December 6, 2022
Time: 1-2:00 p.m. ET

Please dial in at 12:45 p.m. ET to allow time to connect.

U.S. Callers Dial: 833-568-8864

  • Webinar ID: 161 515 2665
  • Passcode: 650433

International Callers Dial: Please check the international numbers available.

  • Webinar ID: 161 515 2665
  • Passcode: 650433

To view the slide presentation during the webinar:

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under “How to Study and Market Your Device,” sub-section “Clinical Studies/Investigational Device Exemption (IDE).” 

If you have questions about these guidance documents, contact [email protected].

If you have questions about this webinar, contact CDRH's Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041 or 301-796-7100.

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