FDA Issues Guidance on Notifications to Help Prevent or Mitigate Medical Device Shortages

The U.S. Food and Drug Administration (FDA) issued the immediately in effect guidance Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency.

Read the Guidance

Facts about the guidance

Manufacturers of devices that are critical to public health during a public health emergency, or for which the FDA determines information on potential meaningful supply disruptions is needed during a public health emergency (described in Section III of the guidance) are required to notify the FDA of an interruption or permanent discontinuance in manufacturing of such devices by Section 506J of the FD&C Act. The guidance:

Includes recommendations about who must notify the FDA about permanent discontinuances or interruptions in manufacturing that could lead to a meaningful disruption in the supply of the device, what information to include in the notification, and how to notify the FDA, for the duration of the COVID-19 public health emergency.
Recommends that manufacturers voluntarily provide additional details to better ensure the FDA has the specific information needed to help prevent or mitigate shortages during the COVID-19 public health emergency.

Upcoming webinar on this guidance

On May 11, 2020, the FDA will host a webinar for medical device manufacturers and others interested in learning more about the guidance.

Questions?

If you have questions about this guidance, contact CDRHManufacturerShortage@fda.hhs.gov and please begin the email subject line with the word “Questions” to expedite our response to your question.