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File number:
FDA-2021-D-0775
Issued by:

Guidance issuance office

Center for devices and radiological health

This guidance document is intended to provide information on the recommended documentation that sponsors should include in pre-market submissions for the FDA’s assessment of the safety and effectiveness of the software functions of the product. ‘device, which are functions that meet the definition of a device under Section 201 (h) of the Federal Act. Food, Drugs and Cosmetics Act (FD&C Act).1 The recommendations in this guidance document relate to the software functions of the device, including software in a medical device (SiMD) and software as a medical device (SaMD).2 When finalized, this document will replace the FDA Guide to Pre-Market Submission Content for Software Contained in Medical Devices released on May 11, 2005, and will update the FDA’s thinking on the documentation that FDA recommends that sponsors include for review of device software functions in pre-market submissions.

This guide identifies the software information typically needed to assess the safety and effectiveness of a device in a pre-market submission. The recommendations in this guide can also help facilitate the FDA’s pre-market review. This guide describes the information that would typically be generated and documented3 during the development, verification and validation of the software design. The least restrictive approach was taken to identify the minimum amount of information that in our experience would generally be required to support a pre-market submission for a device using software. During the pre-market review, the FDA may request additional information necessary for the evaluation of the submission. For example, in order to demonstrate reasonable assurance of safety and efficacy for devices that use software, documentation of the requirements of the Quality System Regulations (QSR) (21 CFR Part 820) is often a necessary part of the pre-marketing submission. As part of QSR design checks, a manufacturer must “establish and maintain device design validation procedures”, which “will include software validation and risk analysis, where applicable”. (21 CFR 820.30 (g)).

The documentation recommended in this guide is based on the FDA’s experience in evaluating the safety and effectiveness of device software. However, promoters can use alternative approaches and provide different documentation as long as their approach and documentation meets the pre-market submission requirements in applicable legal and regulatory provisions. For the current edition of the consensus standard (s) recognized by the FDA and referenced in this document, see the FDA Recognized Consensus Standards Database. For more information on the use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Pre-market Submissions for Medical Devices and Standard Development and use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research.


1 The term “device” is defined in Section 201 (h) of the Federal Food, Drugs and Cosmetics Act (FD&C) to include an “instrument, apparatus, tool, machine, artifice, implant, in vitro reagent or other item, including any component, part or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, alleviation, treatment or prevention of disease, in humans … or intended to affect the structure or any function of the human body … “and” does not include software functions excluded under section 520 (o) of the FD&C law. “

2 See the FDA website on “Software as a medical device (SaMD). “

3 As a reminder, device software manufacturers must create and maintain software documentation in accordance with the requirements of the Quality System (QS) Regulation (21 CFR 820.30 Subpart C – Quality System Regulation Design Controls) .