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USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related to Medical devices earlier this Friday (17 November 2023).

In order to protect the United States from threats, such as emerging infectious diseases and other PHEs, the FDA plays a crucial role. Manufacturers must inform the FDA, during or in advance of a PHE, when they discontinue the manufacture of certain devices or if they interrupt the manufacture of certain devices that may significantly disrupt the United States supply of those devices.

This guidance is intended 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. This guidance also recommends that manufacturers voluntarily provide additional information to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a PHE.

The aim of this draft guidance is to provide a proposed list of drugs and products that are required to be notified to FDA under section 506J of the FD&C Act. As part of its proposed update of the 506J guidance, FDA plans to clarify that manufacturers may notify FDA of supply chain issues at any time, without regard to declared or potential declarations of public health emergencies.

In this guidance document, the FDA provides recommendations on risk-informed frameworks for assessing the credibility of computational modeling and simulation (CM&S) used in medical device regulatory submissions. Models based on physics, mechanistics, or other first principles are covered by this guidance.

The recommendations are intended to improve consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of the credibility evidence of CM&S submitted in regulatory submissions.


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