FDA issues draft device software guidelines in pre-market submissions


The United States Food and Drug Administration (FDA) has released draft sponsor guidance, outlining its thinking on the documentation needed to support the agency’s assessment of the device’s software functions for users. pre-market submissions.

The agency said the guidelines recognize the “rapidly evolving nature of digital health and recent FDA-recognized consensus standards for software” and, when finalized, will serve as an update to the Advice on content of pre-market submissions for software contained in medical devices document published in May 2005.

The changes made to article 520 of the Federal Law on Food, Drugs and Cosmetics (FD&C Act) under the 21st Century Cures Act in december 2016 exclude certain types of software, such as low-risk decision support software such as certain consumer mobile applications and laboratory administrative support software. (RELATED: FDA says mobile apps are no longer devices, Regulatory guidance September 26, 2019; FDA waives regulation of certain types of healthcare software, Regulatory guidance 07 December 2017)

With these changes to Section 520 in mind, the draft guidance describes device software that is under the jurisdiction of the FDA when evaluating the safety and efficacy of devices during the manufacturing process. pre-marketing submission. “These draft guidelines describe the information that would typically be generated and documented during software design development, verification and validation,” the agency wrote.

Software functions

The FDA has made a distinction between “Software in a Medical Device” (SiMD) – defined as software that is part of or controls a medical device – and “Software as a Medical Device” (SaMD), which is software that meets the definition of a device but is not part of the overall hardware of the device. Both SaMD and SiMD are “software functions of the device,” according to the agency.

“For any given product, the term ‘function’ is a separate purpose of the product, which could be the intended use or a subset of the intended use of the product,” the FDA wrote. “For example, a product designed to analyze data has one function: analysis. A product for storing, transferring and analyzing data has three functions: (1) storage, (2) transfer and (3) analysis. “

Overall, the guide covers firmware and other software that controls medical devices, stand-alone software applications, general computing platform software, devices with dedicated hardware and software, and medical device accessories that include softwares. Software for automated manufacturing and quality systems and software that does not meet the device definition was excluded from the guide.

“In general, the recommendations in this guide apply to the device component part of a combined product (such as drug-device and biological device-device combination products) when the device component part includes a software function of the device. device, ”the FDA wrote.

Software device documentation

The FDA has updated the documentation required for sponsors with devices that include software that meets the above specifications. The agency will now consider whether the software needs a basic or enhanced level of documentation based on the risk of the software to the patient, the user of the device, other people, and the environment in which a device is used. In general, improved documentation should be provided by a sponsor if the device is a Class III device, poses a risk of serious injury or death to stakeholders, is “a component of a combination product” or “( a) is intended to test donated blood for transfusion-transmitted infections; or (b) is used to determine the compatibility of the donor and the recipient; or (c) is computer software for blood establishment.

When describing the software of a device, sponsors should include a summary of all important software functionality and features with details such as programming language and compiler versions used, hardware platforms, operating systems. operation, if the device uses standard software, and the expected output version. In addition, sponsors should be prepared to document who will be using the device software, the target patient population, the analysis methodology for any analysis performed by the software, whether the software supports or supersedes the actions of the clinician and, where applicable, additional information on artificial intelligence and machine learning models.

Developers should also document the system and architecture diagram “to facilitate a clear understanding of 1) the modules and layers that make up the system and software, 2) the relationships between modules and layers, 3) the data inputs / outputs and the flow of data between modules and layers, and 4) how users or external products, including IT infrastructure and peripherals (for example, wirelessly connected medical devices) interact with the system and the software, ”wrote the FDA.

In addition, the sponsor must provide a software requirements specification (SRS) – “what the software function will do” and a software design specification (SDS) – “how the requirements of the SRS are implemented,” noted the agency.

Software risk management, maintenance, tests

A risk assessment that includes all “reasonably foreseeable software and hardware hazards associated with the device” and a risk management plan must be included in any pre-market submission of devices whose software meets the criteria. “It should be clear in the risk management plan how the manufacturer plans to assess the overall residual risk against the benefits of the intended use of the device,” the agency wrote.

For device software requiring basic or enhanced documentation, sponsors can either submit a Declaration of Conformity to the currently recognized FDA version of ANSI / AAMI IEC 62304 Medical Device Software – Software Lifecycle Processes or provide the agency with a complete list of the processes and procedures they use to maintain software development and maintenance practices.

When testing the software for verification or validation, the FDA said that the sponsor should document all testing activities, including the version of software used, the results of pass / fail tests, and changes to the software in the event of a failure. ‘failed test results. For software requiring enhanced documentation, “integration level test protocols and reports must be provided, including expected results derived from the requirements and design of the software, actual results which are observed and recorded, objective pass / fail determination (that is, actual results are acceptably equivalent to expected results) and unit and integration test reports, ”according to the agency.

“Unit and integration level test reports must demonstrate that the protocols were performed in an acceptable manner with satisfactory test results and that any unresolved anomalies were deferred in an acceptable manner based on a risk assessment for the candidate version, ”they said.

The FDA noted that it is aware that the information in the draft guidance may differ from the final guidance that it posted on standard software in medical devices. The agency said it plans to update the OTS software guidelines if the final guidelines for the pre-market submission device software are released to make the two sets of guidelines consistent.

Guidance Project: Content of Pre-Market Submissions for Device Software Features

Federal Register Notice

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