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GUIDANCE DOCUMENT

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Draft Guidance for Industry and Food and Drug Administration Staff December 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

Docket Number:
FDA-2021-D-0980
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on a risk-based framework that can be used in the credibility assessment of computational modeling and simulation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.

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