Webcast | Virtual
Event Title
Webinar - Final Guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act
March 4, 2025
- Date:
- March 4, 2025
- Time:
- 2:00 p.m. - 3:00 p.m. ET
On this page:
Summary
On March 4, 2025, the U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested parties to answer questions about the final guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.
Add this to my Calendar
Outlook users: Click link, select Open, then click Save & Close
If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHManufacturerShortage@fda.hhs.gov. Questions should be submitted by January 14, 2025, to be considered for the discussion. We may take live questions during the webinar, as time permits.
Background
The FDA plays a critical role in protecting the United States from threats, such as emerging infectious diseases, and other public health emergencies (PHEs). Section 506J of the FD&C Act requires manufacturers to notify the FDA, during or in advance of a PHE, of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in the domestic supply of that device. The FDA is issuing this guidance to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices. This guidance includes a list of devices, by the FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J (506J Device List). Additionally, this guidance clarifies that the FDA may receive additional voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE.
This guidance serves as the baseline for information about notifications under section 506J during or in advance of any PHE. The guidance clarifies who must notify the FDA, when to notify, a list of product codes for which manufacturers are required to notify FDA in accordance with section 506J, and how to submit notifications.
Webinar Details
Registration is not necessary.
Date: March 4, 2025
Time: 2:00 PM – 3:00 PM ET
Please dial in 15 minutes before the start of the call to allow time to connect.
Passcode: 4#ftYq
Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).
The dial-in information provided below is for participants who will be joining the webinar by phone only.
- U.S. Callers Dial: 833-568-8864 (Toll Free)
- For higher quality, dial a number based on your current location:
- +1 669 254 5252 US (San Jose)
- +1 646 828 7666 US (New York)
- +1 646 964 1167 US (US Spanish Line)
- +1 415 449 4000 US (US Spanish Line)
- +1 551 285 1373 US
- +1 669 216 1590 US (San Jose)
- For higher quality, dial a number based on your current location:
- International Caller Dial: Please check the international numbers available
- Webinar ID: 161 171 8614
- Passcode: 148079
Webinar Materials
Following this webinar, the presentation, printable slides and transcript will be available on this webpage and at CDRH Learn under "Postmarket Activities", sub-section "General Policy.”
If you have questions about this guidance document, please contact CDRHManufacturerShortage@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE).