Dive Brief:
- The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges.
- The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers during the crisis. The guidance document, issued Thursday, outlines examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes.
- While the policy was initially created for the emergency pandemic environment, the FDA wrote in the guidance document that it has “continued to observe supply chain challenges and shortages of medical devices remain widespread.” The agency removed the policy’s expiration date, but it could make revisions in the future.
Dive Insight:
The guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which were severe in some cases early in the pandemic.
The FDA extended the expiration date to 180 days after the PHE expired, which would be Nov. 7, but it has now extended the policy indefinitely due to ongoing challenges.
The FDA wrote throughout the guidance that the policy applies to “limited modifications” and for devices authorized through the PMA and HDE process. Companies can only make modifications if they are “necessary to address current manufacturing limitations, potential shortages or supply chain issues.”
Manufacturers are still required to confirm if any of the changes compromise the safety or performance of the device.
Examples of situations where modification may be allowed include changes to design and manufacturing processes because components are unavailable, device material, manufacturing sites, packaging procedures, device components, and any software or firmware updates because of component changes.
The FDA expects device makers to outline any alterations in their following periodic reports.