Different policies have been taken into account for notifying the FDA about manufacturing interruptions or permanent discontinuations that could result in a significant disruption in the supply of a device in the United States. The key factors outlined below highlight important considerations within this guideline.
Scope:
I. Manufacturer of the following devices:
- • Devices that are critical to public health during a PHE, including those that are life supporting, life-sustaining, or intended for use in emergency medical care or during surgery.
- • Devices for which FDA determines information on potential meaningful supply disruptions is needed during, or in advance of, a PHE.
II. Information to include in the notification
- • The category or name of the device that is the subject of the 506J notification
- • The name of the manufacturer submitting the 506J notification;
- • The estimated duration of the discontinuance or interruption of the device that is the subject of the notification.
- • The reason for the 506J notification, selecting from the following categories:
₋ Requirements related to complying with good manufacturing practices;
₋ Regulatory delay;
₋ Shortage or discontinuance of a component or part;
₋ Discontinuance in the manufacture of the device;
₋ Delay in shipping of the device;
₋ Delay in sterilization of the device;
₋ Demand increases for the device; and/or Facility closure.
III. Failure to Notify
If a manufacturer fails to notify the FDA as required by section 506J, the FDA will issue a letter of noncompliance. The manufacturer must respond within 30 days, explaining the basis for noncompliance. The FDA will make the letter and response public within 45 days on its website, with necessary redactions. However, if the FDA deems the letter issued in error or finds a reasonable basis for non-notification, it won't be posted.
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