Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include in regulatory marketing submissions to assist the agency in evaluating the safety and effectiveness of device software functions.1 The guidance applies to both software in a medical device (“SiMD”) and software as a medical device (“SaMD”).2
This Bulletin summarizes some of the draft guidance contents.
- The guidance covers:
- 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.
- SiMD that meets the statutory definition of “device” in the Federal Food, Drug, and Cosmetic Act is intended to be used for one or more medical purposes without being part of a hardware device.
- SaMD that meets the statutory definition of “a device” is used to control a hardware device or is necessary for a hardware device to achieve its intended use; it is typically embedded within or is part of a hardware device.
- The recommended documentation for a premarket submission depends on the device’s risk to a patient, a device user, or others.
- FDA will consider four risk-based factors to help determine whether the device’s Documentation Level is Basic or Enhanced.
- The purpose of the Documentation Level is to help identify the minimum amount of information that would support a premarket submission, which includes device software functions.
- The Documentation Level is based on the device’s intended use, which includes the design of the device and the intended use of the device as a whole, not the individual device function.
- Basic Documentation should be provided for any premarket submission that includes device software functions where Enhanced Documentation does not apply.
- The four risk-based factors that indicate that Enhanced Documentation should apply are whether the device is: (1) a constituent part of a combination product; (2) categorized as a class III device; (3) intended to test blood donations, determine blood donor and recipient compatibility, or is a Blood Establishment Computer System; or (4) presents a probable risk of serious injury to patients upon failure.
- The term “probable” can include reasonably foreseeable software and hardware risks associated with the device, including those risks resulting from intentional or reasonably foreseeable misuse of the device, prior to the implementation of risk control measures.
- “Probable” risks may also include the likelihood that device functionality is intentionally or unintentionally compromised by inadequate device cybersecurity.
- The term “probable” excludes purely hypothetical risks.
- The Basic and Enhanced levels include similar documentation requirements, including:
- a statement indicating the Documentation Level and explaining why that level was chosen;
- a description of the software, including its features, analyses, inputs and outputs;
- a design chart detailing system and software interactions with users and diagrams showing the relationships between the different elements of the device;
- a risk management plan and an assessment showing that all risks have been appropriately mitigated;
- a Software Requirements Specification (“SRS”) document describing the expectations and needs for the software;
- a complete, detailed explanation of the major revisions made to the software during development; and
- a list of any unresolved software anomalies and an explanation of the effect on safety and effectiveness, as well as a timeframe for correction.
- While there are many similarities between the two levels, there are some notable differences.
- Device software systems in the Enhance Documentation category should submit a Software Design Specification (“SDS”) document or set of SDS documents that allow FDA to understand technical design details of how the software was designed and functions.
- Basic Documentation does not require any SDS documentation.
- Sponsors of devices in the Basic Documentation category must provide a summary description of how the device was tested at the unit, integration, and system levels.
- Sponsors of devices in the Enhanced Documentation category should follow the Basic Documentation requirements and include a description of software testing and submit any unit and integration level test protocols and reports.
- Sponsors of devices in both the Basic and Enhanced Documentation categories should submit a declaration of conformity certifying that the device complies with the applicable FDA-recognized consensus standards; however, if a device is categorized in the Basic Documentation level, the device sponsor may submit a summary of the lifecycle development, configuration management, and maintenance activities.
- If a sponsor of a device software system that falls under the Enhanced Documentation category does not want to submit a declaration of conformity, the sponsor will have to submit all the summaries required under the Basic Documentation category and complete configuration management and maintenance plan documents.
- The draft guidance is detailed and has a number of tables and charts that provide examples and attempt to explain FDA’s current thinking on its explanations. Industry should review the document carefully.
- This guidance provides many recommendations, but sponsors may use alternative approaches and documentation so long as these approaches and documentation satisfy the statutory premarket submission requirements.
- FDA is also soliciting comments on the draft until February 2, 2022, so now is the time for industry to chime in if it wants to be heard.
 www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions (Nov. 2021).
 When FDA finalizes the guidance, it will replace the May 2005 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”