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digital health software pre-certification update: final FDA report revEALED

On September 26, 2022, the U.S. Food and Drug Administration (FDA) released a 31-page final report entitled, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.” The Pre-Cert Program is intended to fast-track digital health products by reducing regulatory hurdles for developers of Software as a Medical Device (SaMD), i.e., software-only products that meet the Federal Food, Drug and Cosmetic Act definition of a medical device through up-front evaluation of a company’s processes and capabilities.

In 2017, the FDA recognized that the current device regulatory framework enacted by Congress more than 40 years prior and incrementally since then, had not been optimized for regulating SaMD devices. This newly-released final report highlights the FDA’s acknowledgement of this need, including new statutory authority after witnessing multiple challenges with implementation of the proposed approach under current statutory authorities. The FDA also found that by limiting participation to nine (9) pilot participants, combined with the need to limit formal implementation of any approaches to De Novo classification, led to fewer devices being made available for consideration under the pilot.

For devices where De Novo classification was appropriate, the approach would have resulted in establishing pilot-specific special controls that would apply not only to the pilot participant’s device, but also to devices where substantial equivalence could be demonstrated to the pilot participant’s device (whether or not they were developed by pilot participants or other manufacturers). As a result, the FDA was simultaneously unable to pilot the program approaches with a broad sample of devices while also being unable to limit the scope of any resulting device classifications.

Following, in April 2018, the FDA released a number of documents to describe its vision and approach to SaMD regulatory oversight and the plan for exploring whether the approach could provide reasonable assurance of safety and effectiveness when compared with the traditional regulatory paradigm. They also released the plan for implementing the pilot and the eventual Pre-Cert Program using current regulatory authorities: Software Precertification (Pre-Cert) Pilot Program, including a working model (v0.1), reflecting the agency’s vision of the pilot and outlining its most critical components. Subsequently, in January 2019, this working model was updated (v1.0) and a corresponding Test Plan was released to guide the Pilot Program.

The January 2019 version of the pilot program explored innovative approaches to regulatory oversight of SaMD products developed by organizations that have demonstrated a robust culture of quality and organizational excellence and that are committed to monitoring real-world performance of their products once commercialized in the U.S. While the pilot was focused on SaMD, the FDA learned that this information is relevant to medical device software in general.

The FDA’s September 26, 2022 final report highlights the following conclusions of the Pilot Program thus far:

  • Evaluating Reasonable Assurance of Safety and Effectiveness in the Pre-Cert Pilot
    This is focused on how information is currently used in pre-market submissions to make regulatory decisions and investigation of the variability of how information is used to help support streamlined review approaches.

    1. The FDA found that standardized, structured data formats could facilitate the development and use of new tools and foster clearer communication between the manufacturer and the FDA.
    2. They also discovered that further development is needed before identifying low-risk devices where an organizational appraisal alone could be relied upon without a pre-market review of the device.
    3. The FDA stated, “a future approach could build on the features of the current regulatory system (QMS), and in some cases, special controls provide a reasonable assurance of safety and effectiveness for certain low to moderate risk devices.” This approach could reduce the need for individual device reviews allowing the FDA to focus on cybersecurity, clinical performance data and other device-specific information.
  • The Need for New Statutory Authority is required to address faster cycles of innovation and the speed of change for medical device software. The challenges in completing the test plan for the pilot under FDA’s current authorities underscore the potential benefits of moving beyond the same medical device legal framework that they have operated under since 1976.
    1. A flexible, risk-based approach to regulation could allow the FDA to tailor regulatory requirements more efficiently for devices based on the latest science, the benefits and risks posed by devices, real-world performance and contribution to promoting health equity.
    2. Risks for such devices can be reduced through swift software and cybersecurity updates throughout the Total Product Lifecycle (TPLC) approach so new legislative authority establishing such approaches could be supplemental to, and not replace, the established regulatory pathways.

In conclusion, the major findings in this report:

  • The Pilot Program is complete and for now, there is no Software Pre-Certification Program.
  • The FDA has determined that the approach described in the pre-certification working model is not practical to implement under our current statutory and regulatory authorities.
  • The pilot informed what new statutory authorities could potentially support for a future regulatory paradigm that builds on these concepts.
  • Appropriate new legislative authority would be necessary to support the development and implementation of a new regulatory paradigm.

In the meantime, the FDA, with leadership from the Center for Devices of Radiological Health’s (CDRH) Digital Health Center of Excellence, will continue to develop policies and tools within current authorities to improve the efficiency and effectiveness of regulatory oversight, including collaborative engagement with the public, such as the Medical Device Innovation Consortium (MDIC).

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? If so, does the software contain AI/ML algorithms? Are the algorithms adaptive or fixed? At NAMSA, our team of regulatory experts have AI/ML experience with a variety of software devices and can guide you through the challenges of this unknown regulatory environment to get your product to market in a timely manner.

If you are interested in speaking with us about FDA-related activities or SaMD, AI/ML development, please submit your request for a complimentary consultations: https://namsa.com/consultants/monica-r-montanez/. You may also learn more about our regulatory consulting services bu visiting: https://namsa.com/services/regulatory/.


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).