- The Food and Drug Administration has acted on industry calls for clarity about supply disruption reporting requirements for medical devices.
- Draft guidance released by the FDA last year worried medtech industry groups, which warned that uncertainty about the scope of the reporting requirements could burden manufacturers and the agency.
- The FDA has responded by proposing a list of devices that are subject to the rules. Officials set out their thinking on the list in new draft guidance. The FDA also finalized other aspects of the text on device shortage reporting requirements it released for consultation last year.
Section 506J of the Federal Food, Drug, and Cosmetic Act requires manufacturers of certain devices to tell the FDA in advance if they are permanently ending production of the product or face an interruption that is likely to meaningfully impact supply before or during a public health emergency (PHE). The FDA released draft guidance on the topic for consultation last year.
In response, AdvaMed said “it is vital for FDA to publish a list of procodes that are subject to the section 506J reporting requirement.” The request, which was echoed by the Medical Device Manufacturers Association, reflected a belief that FDA’s attempts to clarify the scope of the reporting requirements had failed to clear up uncertainty.
AdvaMed said the phrases “life-supporting, life-sustaining, or intended for use in emergency medical care” and “use during surgery” capture devices that may not be relevant to PHEs, or may have “dozens of competitive offerings” that mitigate the impact of supply disruptions. The trade group said uncertainty may lead to overreporting, burdening industry and the FDA.
The FDA has listened. In the agency’s final guidance document, the agency has added a section titled “506J Device List.” The section currently contains placeholder text. Officials will add the proper text once they have finalized the draft guidance they also released this week.
In the draft guidance, the FDA proposes text for the “506J Device List” section. The draft text outlines how the FDA will determine if a device meets the criteria for shortage reporting. The current list features 285 product codes, ranging from airway connectors to wound dressings.
The FDA plans to host an advisory committee meeting to discuss the list, and other supply chain resiliency and device shortages issues, on Feb. 6, 2024. The draft guidance is open for comment for 90 days.