Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification) (original) (raw)

Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification)

This page provides an electronic method for manufacturers of certain medical devices to submit 506J notifications to notify the FDA of an interruption or permanent discontinuance in manufacturing during or in advance of a public health emergency. Manufacturers should submit 506J notifications in the method that is most convenient. The webform is updated to include new information from Establishment Registration and Device Listings.

OMB # 0910-0491, exp. 06/30/2024

For help using the notification options below, refer to the following How To documents:

*** How to use the FDA 506J Notification Webform ** *** How to use the 506J Notification Spreadsheet Template ** *** Online 506J Notification Submission Methods: Frequently Asked Questions** *** Common error messages when using the 506J Notification webform **

Notify FDA using webform:

Complete the Online Notification using this form, you can submit individual notifications.

OR

Notify FDA using a spreadsheet:

Complete the Online Notification and submit a spreadsheet with a batch of notifications.

OR

Indicate there is not an interruption or permanent discontinuance:

If you are currently not experiencing an interruption or permanent discontinuance in manufacturing that requires the submission of a 506J notification, you may indicate no current interruption or permanent discontinuance.