Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Food and Drug Administration. Office of Combination Products, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval Government Regulation Software -- legislation & jurisprudence Software -- standards Software Design United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005, and updates FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. The recommendations in this guidance are intended to facilitate FDA’s premarket review. This guidance describes information that would be typically generated and documented during software development, verification, and validation. The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses software. During premarket review, FDA may request additional information that is needed to evaluate the submission. For example, in order to demonstrate a reasonable assurance of safety and effectiveness for devices that use software, documentation related to the requirements of the Quality System Regulation (QSR) (21 CFR Part 820) is often a necessary part of the premarket submission. As part of QSR design controls, a manufacturer must “establish and maintain procedures for validating the device design,” which “shall include software validation and risk analysis, where appropriate” (21 CFR 820.30(g)). The documentation recommended in this guidance is based on FDA’s experience evaluating the safety and effectiveness of device software. However, sponsors may use alternative approaches and provide different documentation so long as their approach and documentation satisfy premarket submission requirements in applicable statutory provisions and regulations. For the current edition(s) 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 and Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research. As stated above, this guidance identifies the software information FDA considers to generally be necessary to support a premarket submission. The recommendations in this guidance are also intended to facilitate FDA’s premarket review. FDA anticipates that the Agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed. However, CDRH intends to review any such information if submitted at any time. 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:
- 9918662583106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662583106676