Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Postmarket

Published

November 17, 2023

Last updated

November 16, 2023

Description

Guidance document on notifying FDA of permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act.

Organization

Country / Region

United States

License

Other (Public Domain)

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