The FDA Center for Devices and Radiological Health (FDA CDRH) issued a final guidance for manufacturers that describes how to notify the agency of supply issues during the COVID-19 pandemic.
The guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, aims to mitigate equipment shortages by requiring manufacturers to communicate any interruptions in their supply chains that could affect hospitals’ ability to treat patients with COVID-19.
“This information is truly critical to help us assess, prevent, and mitigate shortages during this public health emergency,” says Katie O’Callaghan, deputy director of the Division of All Hazards Response, Science and Strategic Partnerships in the CDRH Office of Strategic Partnerships and Technology Innovation. For manufacturers concerned about sharing sensitive data, O’Callaghan confirmed that “any information that is provided which is trade secret or confidential will be treated as such, consistent with all of our usual laws.”
According to the guidance, device manufacturers must notify the agency at least six months before the date of a “meaningful” discontinuance or interruption or, if that is not possible, no later than seven days after the event. The agency outlined the following examples of meaningful manufacturing disruption circumstances that would require notification:
- The device is life-supporting, life-sustaining, or intended for use in emergency medical care.
- The device is intended for use during surgery.
- The device is used to diagnose, cure, treat, mitigate, or prevent COVID-19.
- The device would be in higher-than-typical demand during the response to the COVID-19 pandemic compared to a similar period.
The FDA asks manufactures to include the following information in their notification reports:
- Appropriate identifying information and manufacturer name
- Marketing submission number
- FDA Establishment Identifier number
- Device name and product code
- Contact information of reporter
- The reason(s) for and estimated duration of discontinuance or interruption
- COVID-19-specific impacts
- Mitigation plans
- Information on production capacity and market share
Section IV of the final guidance document provides an example of a completed notification report and detailed information about who must submit the notification and how to do so. After the initial notification, the FDA is asking manufacturers for updates every two weeks and a timeline for recovery.