Shortages of medical devices can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.
Notify the FDA Under Section 506J of the FD&C Act
Under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers of the following devices must notify the FDA of an interruption or permanent discontinuance in manufacturing:
- Devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery
- Devices for which the FDA determines information on potential meaningful supply disruptions is needed during a public health emergency.
The FDA issued an 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: Guidance for Industry and Food and Drug Administration Staff. This guidance includes:
- A reference to a table of the device types and corresponding product codes that the FDA recommends manufacturers consider in determining whether they are required to notify the FDA pursuant to Section 506J during the COVID-19 pandemic. To view the table, see Medical Device Types to Help Determine Section 506J Notification Obligations.
- An example notification intended to illustrate the type of information that the FDA recommends be included in a notification.
To submit a notification, email your information to CDRHManufacturerShortage@fda.hhs.gov and begin the email subject line with the word "Notification." A notification must include the information required by section 506J(a) of the FD&C Act.
If you have questions, email CDRHManufacturerShortage@fda.hhs.gov and begin the email subject line with the word "Question" to expedite our response to your questions.
If a device type is not included on this table, but you believe it requires a notification under Section 506J of the FD&C Act, or if you have questions regarding the device types on this table, email CDRHManufacturerShortage@fda.hhs.gov and include "Question" in the subject line of the email.
For more information, see Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency.
Report Other Device Supply Chain Issues
The FDA is interested in hearing from health care facilities and providers experiencing difficulty obtaining devices, as well as from other stakeholders who may be able to help mitigate potential shortages. You may email the FDA at email@example.com.