The recommended documentation for a premarket submission depends on the device’s intended use and potential risk to patients or users of the device. 

On November 4, 2021, FDA issued draft guidance recommending documentation that should be included in premarket submissions for FDA’s review of device software functions. FDA will be accepting comments and suggestions on this draft guidance in the Federal Register for 90 days. When final, the guidance will supersede FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, which FDA issued on May 11, 2005.

The scope of FDA’s draft guidance covers software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic Act. This includes software in a medical device (SiMD), such as software that is embedded in a hardware device and is necessary for the device to achieve its intended function, and software as a medical device (SaMD), such as software that is intended to be used for one or more medical purposes without being part of a hardware device. The guidance does not apply to automated manufacturing and quality system software or software that is not a device. Further, the guidance does not apply to software-related documentation that may be needed to evaluate postmarket software device issues, nor does it provide recommendations regarding how device software should be developed, verified and validated. The guidance only provides information regarding recommended documentation that sponsors should include in premarket submissions to enable FDA’s evaluation of device software functions’ safety and effectiveness.

The recommended documentation for a premarket submission depends on the device’s intended use and potential risk to patients or users of the device. FDA has created two levels for the recommended documentation for a device: basic documentation and enhanced documentation. Basic documentation is necessary for all device premarket submissions that include software functions. However, if any of the four risk-based factors below apply to a device, its premarket submission documentation level rises to enhanced:

1. The device is a constituent part of a combination product (see 21 CFR 3.2(e));
2. The device (a) is intended to test blood donations for transfusion-transmitted infections; or (b) is used to determine donor and recipient compatibility; or (c) is  Blood Establishment Computer Software (see 21 CFR 864.9165);
3. The device is classified as class III (see 21 CFR 860.3(c)(3)); or
4. A failure or latent flaw of the device software function(s) could present a probable risk of death or serious injury (see 21 CFR 803.3(w)), either to a patient, user of the device or others in the environment of use.

With respect to the fourth factor, it is a device sponsor’s responsibility to proactively and comprehensively consider any risks, including, among other concerns, (a) reasonably foreseeable software and hardware risks associated with the device from intended use or intentional or reasonably foreseeable misuse and (b) the likelihood that the device could be compromised due to cybersecurity risks.

The guidance specifically sets forth FDA’s recommendations for information to be included in premarket submissions for both basic and enhanced documentation levels. A device sponsor typically generates and documents the recommended information during software development, verification and design validation. The information to be included is designed to help FDA evaluate the safety and effectiveness of a device in a premarket submission. The major difference between the two documentation levels is that the basic documentation level does not require submission of the software design specification, while the enhanced documentation level does require submission of this information.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Coleen W. Hill, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

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