Dive Brief:

• The Food and Drug Administration has finalized guidance on manufacturers notifying the agency of changes that could likely disrupt the supply of medical devices. 
• Officials created the guidance to help manufacturers comply with the requirement to provide timely information about disruptions during or before public health emergencies. 
• The final version, which the agency published Monday, retains the vision the FDA proposed in its second draft and adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.

Dive Insight:

Industry groups pushed back against the first draft in 2022, warning that the scope of the document may cause overreporting. The FDA responded in 2023 by proposing a list of product codes that would be subject to the reporting requirements. At the time, the FDA suggested adding “506J Device List” and “Additional Notifications” sections to the guidance and proposed accompanying draft texts in a separate document. 

The final guidance features updated versions of the draft sections the FDA released for consultation in 2023. The “506J Device List” section describes the development of the list of product codes affected by the guidance. 

Officials selected devices that they consider critical in any public health emergency, as well as products that may be critical in specific crises. The FDA said it expects the list to evolve over time and will assess the need to add more devices as emergencies arise. The flexibility reflects the divergent impact on health systems of emergencies such as respiratory illnesses and events that cause traumatic burns.

Changes to the 2023 draft include new details on the information the FDA collected during the consultation and an advisory committee meeting, plus a comparison of the agency’s list and a similar initiative by the Centers for Medicare and Medicaid Services.

Officials largely retained the draft text proposed for the new section on additional notifications. The FDA proposed adding the section after lawmakers used the 2023 Omnibus Appropriations Bill to clarify that the agency may receive voluntary notifications about device supply disruptions at any time. 

Like the draft text, the final guidance says the FDA has “always accepted voluntary submissions of information across many topics, including device supply chain matters” and the reporting requirements do not affect that acceptance. The final guidance includes new lines about the role reporting played in the pandemic and how the FDA uses notifications to analyze device supply and demand.