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GUIDANCE DOCUMENT

Select Updates for the 506J Guidance: 506J Device List and Additional Notifications Draft Guidance for Industry and Food and Drug Administration Staff November 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0053
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA has developed this draft guidance to propose select updates to the FDA guidance document “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” (hereafter referred to as the “506J guidance”). This draft guidance provides a proposed list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act (hereafter referred to as the “506J Device List”). Additionally, FDA is proposing to update the 506J guidance to clarify that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency. The existing 506J guidance remains in effect, in its current form, until this draft guidance is finalized. FDA is seeking feedback on revisions proposed in this select update.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0053.

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