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3 Recent FDA Events Depict How AI/ML Will Change the Medical Device Industry

By Quality Means Business

Understandably, as medical devices become more novel and sophisticated, the requirements and standards have followed suit. Early evidence of a more integrated industry is most noticeable in the requirements around premarket notification submissions (510(k)’s). The shift from mail-in to electronic submissions, with updated standards has become more palpable with the FDA’s commitment to the development of electronic submission templates taking form in the latest nonbinding recommendations “Electronic Submission Template for Medical Device 510(k) Submissions” (FDA,2022). A commitment derived from the Secretary of Health and Human Services to Congress’s Medical Device User Fee Amendments of 2017 (MDUFA IV). In the long run, the FDA are aligned with the rise of a more integrated and technologically savvy industry.

After monitoring the industry’s transition to solidify electronic 510(k) submissions as a requirement by October 1st, 2023, we would be remiss to ignore that this change is intended to represent one of multiple alterations to submissions to achieve a fully electronic format. Not to mention, the budding and red-hot rise of Artificial Intelligence and Machine Learning based Software as a Medical Device (AI/ML SaMD) will soon reshape how the Medical Device industry operates.

Here are 3 ways AI/ML SaMD will reshape the Medical Device industry in the next 3 years:

  1. The launch of “Quality in 510(k) Review Program Pilot”. A free alternative option that became available back in September 2018 began the shift towards electronic submissions by providing users with prompts and consisting of relevant questions. In June 2022, the emergence of eSTAR has stimulated the SaMD terrain by incorporating technical review timelines and user notifications for incomplete applications. Product questionnaires/surveys are also meant to be part of the application process and hold a section for artificial intelligence and machine learning products. This program will also have rippling effects that extend from R&D to marketing/commercialization strategies.

  2. The development of Good Machine Learning Practices (GMLP). Artificial Intelligence and Machine learning have the ability to transform healthcare through insights generated from massive amounts of data. Most of this data however will contain sensitive information, therefore a concerted effort between the United Kingdom’s Medicine and Healthcare products Regulatory Agency (MHRA), the U.S. Drug and Food Administration (FDA), and Health Canada have taken place to finalize 10 guiding principles that should ensure safe yet effective medical devices.

  3. Patient centered development and inclusion in algorithms. Algorithms and software that use clinical policies and practices that emphasize accountability, trust, and transparency for both end-users and patients alike will be key. The ability to demonstrate functionality accurately and reliably while handling massive amounts of sensitive data will be the mark of an effective SaMD.

The accumulation of real-world evidence and removal of bias during development will open new doors in healthcare and diagnostics. However, the applications of SaMD features may be broader than we think. Automation in healthcare is a cornerstone left widely underdeveloped. Who knows what innovations are just around the corner.


  1. Good Machine Learning Practice for Medical Device Development: Guiding Principles, Food and Drug Administration, 2021.

  2. Gowda, Vrushab. “A Closer Look at FDA’s Newly Released AI/ML Action Plan.” Bill of Health, 18 Feb. 2021, Accessed 17 Jan. 2023.

  3. “How FDA Regulates Artificial Intelligence in Medical Products.” The PEW Charitable Trusts, 5 Aug. 2021, Accessed 17 Jan. 2023.

  4. Khan, Taimoor. “FDA Action Plan for AI/ML in SaMD (Software as a Medical Device).” StarFish Medical, Accessed 17 Jan. 2023.

  5. Lenz, Adrienne R. “FDA Continues Discussion of AI/ML Software Medical Devices.” FDA LAW BLOG, 21 Jan. 2021, Accessed 17 Jan. 2023.

  6. Miller, Michaela. “FDA Publishes Approved List of AI/ML-Enabled Medical Devices.” IQVIA, 29 Oct. 2021, Accessed 17 Jan. 2023.

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