US: Implementation of Notification Requirements to Protect Medical Device Supply Chains

ARQon
May 6, 2022
2 min read

On 11 January 2022, the US Food and Drug Administration (FDA) released a draft guidance on notifying them of permanent interruption or discontinuation in manufacturing of a device that is likely to lead to a meaningful disruption of supply of that device during or in advance of a public health emergency, such as COVID-19. This guidance is to assist manufacturers in providing timely and informative notifications on changes in production of select devices to prevent shortage of these devices.

Who must notify FDA

Manufacturers of the following devices must notify FDA of permanent discontinuation or an interruption in manufacturing that would lead to significant disruption in supply:

Devices that are critical to 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 FDA determines information on potential meaningful supply disruption is needed during, or in advance of, a public health emergency.

Note that FDA may recommend to manufacturers which devices or device types are considered critical during that public health emergency itself as it develop, as devices critical in some emergencies may not be in consider critical in others.

Key information about notifications When supply of a medical device that is identified as critical in a public health emergency is facing interruption or discontinuation, the manufacturer must submit notifications of:

“a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an approved modification of the device);”
“an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States;”
“the reasons for such discontinuance or interruption.”

Manufacturers must submit a notification at least six months in advance of a permanent discontinuation 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 is not possible, the alternative is to submit it “as soon as practicable”. This means the manufacturer should submit the application no later than 7 calendar days after an interruption in manufacturing occurs, or the manufacturer decides to permanently discontinue the device.

In addition, FDA recommends that manufacturers provide updates every two weeks on the nature of the situation, including the expected timeline for recovery.

Sources

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Draft Guidance for Industry and Food and Drug Administration Staff