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 specific devices or an interruption in the manufacture of certain devices, which leads to disruption in the 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 manufacturers of the following device types must notify:
- Devices 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).
- The product is in typical demand (for example, PPE kits).
When to Notify?
Manufacturers must submit a notification at least six months before a permanent discontinuance of the device. However, 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 will likely 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, contact information, and UDI number.
Failure to Notify.
If a manufacturer fails to provide notification of a permanent discontinuance following the timelines, FDA will issue a letter to that manufacturer informing the manufacturer of such failure. The manufacturer must respond to FDA’s letter no later than 30 calendar days after the issuance of the FDA’s letter.
About the Author
“Neethu Anto, Regulatory Professional from I3CGlobal, is one of the best performers, so passionate to share her knowledge and experience with the medical device fraternity.”
