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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 The recommendations in this guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD).2 When final, this document will replace FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005, and it will update FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.
This guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in this guidance also may help facilitate FDA's premarket review. This guidance describes information that would be typically generated and documented3 during software development, verification, and design 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 devices 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 satisfies premarket submission requirements in applicable statutory provisions and regulations. 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 and Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.
1 The term "device" is defined in 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act to include an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man ... or intended to affect the structure or any function of the body of man..." and "does not include software functions excluded pursuant to section 520(o) of the FD&C Act."
2 See FDA website on "Software as a Medical Device (SaMD)."
3 As a reminder, manufacturers of device software must create and maintain software-related documentation in accordance with the requirements of the Quality System (QS) Regulation (21 CFR 820.30 Subpart C – Design Controls of the Quality System Regulation).