Devices

Device Discontinuance and 506J List Guidances

FDA has issued a final guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act, to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices. The document also recommends that manufacturers voluntarily provide additional information to better ensure the agency has the specific information it needs to help prevent or mitigate shortages during or in advance of a public health emergency (PHE).

The guidance says Section 506J requires manufacturers to notify FDA, during or in advance of a PHE, of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacturing of certain devices that is likely to lead to a meaningful disruption in the supply of that device in the U.S.

“This guidance serves as the baseline for information about notifications under Section 506J during or in advance of any PHE,” it says. “If FDA determines it is appropriate, we may issue individual, PHE-specific guidance documents, among other potential options. Such decisions will be made on a case-by-case basis and will be determined by the specific situation and informational need.”

The agency also published a draft guidance, Select Updates for the 506J Guidance: 506J Device List and Additional Notifications, to fulfill a requirement in the FY 2023 Omnibus that FDA issue or revise guidance on requirements under Section 506J and include a list of each device product code for which a manufacturer of such a device is required to notify HHS under the 506J requirements. The Omnibus also directed the agency to issue guidance “to facilitate voluntary notifications.” FDA says it will incorporate the updates proposed in the draft as one final guidance after obtaining and considering public comment on the proposed select updates.

Concurrent with publishing the two guidances, FDA announced a 2/6/2024 advisory committee meeting to discuss medical device supply chain resiliency and device shortage issues, including the 506J device list.

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