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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff." Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform "in silico" device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of CM&S used in medical device regulatory submissions. The guidance is 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.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.