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GUIDANCE DOCUMENT

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance for Industry and Food and Drug Administration Staff November 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-0980
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote 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 CM&S credibility evidence submitted in regulatory submissions.

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Submit Comments Online

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-2021-D-0980.

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