What is FDA’s Section 506J Notification
Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices. Which leads disruption in supply of that device in the United States. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19.
Who Must Notify?
The manufactures of the following device type must notify:
- Devices that are critical to public health: e life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery.
- Whether the device is used to diagnose, cure, treat, mitigate, or prevent COVID-19 (example: diagnostic and serological specimen collection kits).
- Product which is in typical demand (example PPE kits).
When to Notify?
Manufacturers must submit a notification at least six months in advance of a permanent discontinuance of the device. If that timeframe is not possible, notification should be done “as soon as is practicable.
The information to be included in the Notification:
- The reasons for such discontinuance or interruption.
- An interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply.
- A permanent discontinuance in the manufacture of the device.
- Manufacturer name, FDA Establishment Identifier (FEI), name, product code, and contact information, UDI number.
Failure to Notify.
If a manufacturer fails to provide notification of a permanent discontinuance in accordance with the timelines, FDA will issue a letter to that manufacturer informing the manufacturer of such failure. The manufacturer must respond to FDA’s letter not later than 30 calendar days after issuance of FDA’s letter.
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