FDA Proposes Medical Device Software Documentation Requirements

Recently, we reported on various guidances the FDA intends to issue in the coming year. The documents were heavy on assuring the safety and effectiveness of software and clinical decision software (CDS).

FDA “Thinking”

On November 4, 2021, the agency issued a 39-page proposed guidance for "Premarket Submissions for Device Software Functions." The document describes the agency's "thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions."

The document pertains to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD).

For the example, the agency may request additional information that is needed to evaluate software related to the requirements of the Quality System Regulation (QSR). 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.”

The thinking incorporates recent changes made by the 21st Century Cures Act. It also considers the rapidly evolving nature of digital health and recent FDA recognized consensus standards related to software.

This guidance does not apply to automated manufacturing and Quality System software or software that is not a device.

Recommended Documentation

Here's the recommended documentation the agency says sponsors should include in premarket submissions:

• firmware and other means for software-based control of medical devices;
• stand-alone software applications;
• software intended to be operated on general-purpose computing platforms;
• dedicated hardware/software medical devices; and
• accessories to medical devices when those accessories contain or are composed of software.

In addition, the guidance provides an outline of the recommended documentation for each software documentation element and corresponding "basic" or "enhanced" documentation level.

For example (one of many), when it comes to software specifics, the agency will want to know:

• What programming languages and compiler versions are used?
• What hardware platforms are used?
• What operating systems are used (if applicable)?
• Does the device use Off-The-Shelf (OTS) software(s)?
• What is the intended release version? If the intended release version is different from the documentation’s version, explain the differences.

Submit Comments

As noted, the agency's thinking covers 39 pages. There's lots to digest.

You've got 90 days from the date of issuance to comment on the proposed guidance.

Submit electronic comments to https://www.regulations.gov.

Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.