Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Computer Simulation Device Approval Government Regulation United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- FDA has developed this guidance document to assist industry and FDA staff in assessing the credibility of computational modeling used to support medical device premarket submissions (i.e., Premarket Approval (PMA) Applications, Humanitarian Device Exemption (HDE) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests) or qualification of Medical Device Development Tools (MDDTs). In the context of this guidance, credibility is defined as the trust in the predictive capability of a computational model. Computational models can be used in a variety of ways in medical device regulatory submissions, including to perform ‘in silico’ device testing or to influence algorithms within software embedded in a device. Regulatory submissions often lack a clear rationale for why models can be considered credible for the context of use (COU). This guidance provides a general risk-informed framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. For the purposes of this guidance, CM&S refers to first principles-based (e.g., physics-based or mechanistic) computational models, and not statistical or data-driven (e.g., machine learning or artificial intelligence-based) models. This guidance is intended to help improve the consistency and transparency of the review of CM&S, 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 reviewed by FDA staff. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (42 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918733188906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918733188906676