FDA Hopes Draft Device Software Guidance Provides “Clarity, Simplicity”


Last week, the United States Food and Drug Administration released draft guidelines for its content of pre-market submissions for device software functions.

the advice, published online Nov. 4, intended to provide information regarding recommended documentation to be included in pre-market submissions to the FDA to assess the safety and effectiveness of the device’s software functions.

The FDA’s draft recommendations relate to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), in particular – and describe the data that would be generated and documented during the design, development, verification and validation of the software.

The guidelines, once finalized after a period of public content, would replace the FDA’s more than 16-year-old guidelines for the content of pre-market submissions for software contained in medical devices.

This is a substantial overhaul of this document, which has been first published in May 2005, when the existing technological landscape could not have been imagined. Just as the maturity and capabilities of medical devices have evolved considerably since then, so has the agency’s regulatory approach.

The new project “describes information that the FDA considers important when evaluating the safety and effectiveness of device software with one or more device functions, including both software in a device. and software as a medical device, “said Bakul Patel, director of the FDA Center of excellence in digital health at the Center for Radiological Devices and Health.

“We are anticipating this guidance project, which fulfills the FDA’s commitment in MDUFA IV, will bring clarity, simplicity and alignment with current best practices and recognized voluntary consensus standards, once finalized, ”he added.

Comments can be submitted online until February 2, 2022.

“We look forward to receiving feedback on this draft guidance and providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health,” said Patel.

Speaking a year ago about the promise and potential of medical technology, especially as artificial intelligence and machine learning evolve, Patel took note of the total product lifecycle approach. of the FDA for software as AI-powered medical devices.

The goal, he said in October 2020, was that “FDA oversight would provide the level of trust to users, while taking advantage of transparency and pre-market assurance, as well as continuous monitoring of these products that learn about And we are looking to see what we can do to improve this framework in the future and understand how the regulatory system can enable that. “

Last month, meanwhile, the agency released another document: a list of “guiding principles” to help promote the safe and effective development of medical devices using AI.

Hope is to lay the groundwork for what the FDA calls Good practice of machine learning. “As the field of AI / ML medical devices evolves, the best practices and consensus standards of GMLPs must also evolve,” according to the agency.

“As technology continues to advance all facets of healthcare, software has become an important part of many products and is widely integrated into medical devices,” Patel said last week, announcing the draft guidelines on device software.

“The FDA recognizes this changing landscape and seeks to provide our latest thoughts on regulatory considerations for device software functions that are aligned with current standards and best practices. “


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