- The FDA is ask for feedback on the procedures for notifying an interruption or definitive cessation of the production of a medical device.
- the orientation projectwhich is open for comment until March 11, aims to help manufacturers provide timely information about disruptions during public health emergencies and thereby reduce the risk of shortages.
- Congress has imposed reporting requirements on device manufacturers under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which gave the FDA authority intended to help prevent or alleviate medical device shortages for the first time. The project aligns closely with current policy.
Overview of the dive:
Having gained authority through the CARES Act of 2020, the FDA has made guidance on implementing the reporting requirement one of its key regulatory priorities for 2022. The agency ticked that item off its priority list this week by releasing a 16-page document that outlines who should send notifications, when and how they should do so, as well as how the FDA determines whether a device is in short supply.
In future public health emergencies, the FDA could follow the same approach it took for COVID-19 and create a table of device types it says will be critical to public health during the crisis. However, the draft leaves room for the agency to adopt other approaches “as appropriate” in future crises.
If manufacturers are unsure whether to notify the FDA, the draft guidance recommends that they assess whether their devices are life-saving, life-sustaining or used in emergency medical care, are used in surgery or are necessary to diagnose, cure, treat, mitigate or prevent seizure-related illness. Manufacturers should also consider whether the crisis will increase demand for their device.
Manufacturers who meet the criteria must submit notifications at least six months before permanently ceasing production or discontinuing manufacturing as there is likely to be a significant disruption in supply. When six months’ notice cannot be provided, manufacturers must notify the FDA “as soon as possible.” The FDA wants to be notified of stop decisions and interruptions within seven calendar days.
Other sections of the guidelines cover what information the FDA expects manufacturers to submit in notifications, how to send notifications, and penalties for non-compliance. The FDA also used the draft to describe how it determines which devices are in short supply, explaining that it evaluates notifications and other sources of supply and demand information to make a decision.
The guidelines are not intended to replace the text The FDA was created to help manufacturers file notifications during the COVID-19 pandemic. The agency plans to retire the COVID-19-specific document when the coronavirus-related public health emergency ends. If the draft document is finalized before the end of the health emergency, the COVID-19 text will continue to apply to shutdowns related to the crisis.