Notify the FDA About a Medical Device Supply Issue (original) (raw)
Shortages of medical devices can occur for many reasons, including natural disasters, geopolitical conflict, recalls, manufacturing and quality problems, delays, and discontinuances.
On this page:
- How to Submit a 506J Notification
- Notifications Required Under Section 506J of the FD&C Act
- Questions about 506J Notifications
- Contact the FDA About Other Medical Device Supply Issues
How to Submit A 506J 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.
Manufacturers may use the webform to submit 506J notifications. However, if you do not wish to use the webform, manufacturers may email 506J notifications to CDRHManufacturerShortage@fda.hhs.gov and begin the email subject line with the word "Notification."
Notifications Required Under Section 506J of the FD&C Act
Under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), during, or in advance of, a public health emergency, 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.
Section 506J of the FD&C Act requires that manufacturers submit required notification at least six months in advance of a permanent discontinuance in manufacturing of a device or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the United States. If that timeframe is not possible, Section 506J of the FD&C Act requires notification to be done "as soon as practicable." Note that outside of declared public health emergencies, the FDA encourages device manufacturers to submit 506J notifications on a voluntary basis.
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 other questions about submitting 506J notifications, please see Supply and Shortages of Medical Devices: Frequently Asked Questions.
For more information about submitting 506J notifications, see Medical Device Supply Chain and Shortages.
For more information about the categories of devices the FDA has determined to be in shortage at this time, see Medical Device Shortages List.
Contact the FDA About Other Medical Device Supply Issues
The FDA is interested in hearing from health care facilities and providers having trouble obtaining medical devices, as well as from other stakeholders who may be able to help mitigate potential shortages. You may email the FDA at deviceshortages@fda.hhs.gov.
For more information, see Office of Supply Chain Resilience (OSCR).