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FDA Releases draft guidance: content of premarket submissions for device software functions

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency has issued draft guidance—“Content of Premarket Submissions for Device Software Functions” (November 3, 2021).

Per the FDA: “As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide the latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”

What Should Medical Device Sponsors Know?
The issuance of the draft guidance, part of the FDA’s MDUFA IV Digital Health commitments, describes information that the FDA deems important during its evaluation of the safety and effectiveness of device software with one or more device functions. This includes both software in a medical device (SiMD) and software as a medical device (SaMD).

  • The draft guidance is intended to provide information regarding the recommended documentation to include within FDA premarket submissions , required for evaluation of safety and effectiveness of device software functions.  
  • The proposed recommendation in the draft guidance pertains to device software functions, including both SiMD and SaMD. The document describes a subset of information that would typically be generated and documented during software design, development, verification and validation.

Next Steps
The FDA welcomes continued feedback through public docket (mailto:FDA-2021-D-0775@www.regulations.gov) and looks forward to engaging with stakeholders on these efforts. Comments must be submitted by February 2, 2022.

How can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.

Does your software product meet FDA’s definition of a medical device? At NAMSA, our team of regulatory experts have a wide-range of SaMD, AI/ML experience with a variety of software devices and can help guide you through the challenges of this unique regulatory environment to achieve accelerated development timelines and market introduction.

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.

Monica R. Montanez

Monica R. Montanez, MS, RAC, CQA currently serves as NAMSA's Principal Strategy Consultant. Monica has over twenty years’ experience in the medical device industry in Regulatory Affairs and Quality Assurance. Her primary focus is navigating the regulatory pathways for electro-mechanical and software driven medical devices worldwide. She has received clearance of many 510(k)s and approval of new indications for PMA device(s) of which 90% involved software. She has broad regulatory expertise in several areas of digital health, including: Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), mobile medical apps, clinical decision support software, telehealth, artificial intelligence, machine learning, interoperability, cybersecurity and human factors engineering, including wireless medical devices -radio frequency (RF), electromagnetic compatibility (EMC) and electromagnetic interference (EMI). While in industry, she assisted in the development of FDA 510(k) guidance and FDA Software guidance directly with FDA. Monica holds a Masters of Science (MS) degree in Regulatory Science (RS) from the University of Southern California (USC) School of Pharmacy. Currently. she holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).