Shortages of medical devices can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.
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 submit a notification:
- The FDA has developed an online webform to assist manufacturers in submitting 506J notifications. Manufacturers may submit both initial notifications and update notifications online using the webform.
- For manufacturers submitting a large number of notifications who do not wish to enter the information directly into the webform, please choose the option, “Submit Notifications Using a Spreadsheet” to upload the spreadsheet template through the webform.
- The FDA recommends that you utilize the webform to submit your 506J notifications. However, if you do not wish to utilize the webform, manufacturers may email their information to CDRHManufacturerShortage@fda.hhs.gov and begin the email subject line with the word "Notification." Section V of the 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 (Revised), provides an example 506J notification intended to illustrate the type of information that the FDA recommends be included in a notification.
Questions about 506J Notifications
If you have questions about using the webform to submit a 506J notification, please see Online 506J Notification Submission Methods: Frequently Asked Questions.
If you have questions about submitting a 506J notification, please see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
For more information about submitting 506J notifications, see Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency.
For more information about the categories of devices the FDA has determined to be in shortage at this time, see Medical Device Shortages During the COVID-19 Public Health Emergency.
Notify FDA About 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 firstname.lastname@example.org.