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FDA Releases Updated Working Model for Software Precertification Program

The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products).  The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.

Under the Software Precertification Program, the extent of regulatory scrutiny for SaMD products would depend on both the healthcare situation or condition (critical, serious, or non-serious) and the significance of the SaMD’s function (e.g., treat or diagnose, drive clinical management, or simply inform).  Thus, products that inform in non-critical situations would not require premarket review by the FDA, while those that drive clinical management in critical situations will be required to go through a streamlined premarket review.

At present, the agency is piloting the Software Precertification Program with nine companies, including large manufacturers of medical devices and pharmaceutical products, multinationals that design and market software and consumer electronics, and startups that use computer technologies for research in genomics or diabetes management.  When the Software Precertification Program is fully deployed, it will be voluntary and open to all interested companies.  Companies that elect to participate and that successfully demonstrate excellence in five key areas (product quality, patient safety, clinical responsibility, cybersecurity responsibility, and proactive culture) would qualify for a more streamlined premarket review of their SaMD products.  The designation is not permanent, however, and pre-certified organizations would have to share their key performance metrics with the FDA to maintain their precertification designation.

The recently updated Working Model is more detailed than the previous version 0.1 (issued in April 2018) and version 0.2 (issued in June 2018).  The updated Working Model responds to and incorporates public comments received by the FDA through October 31, 2018.  Among changes introduced in this version are the description of regulatory review elements, examples of sources and analytics types used for assessing real-world performance of SaMD products, and the clarification of intent to consider in the future an accreditation program for third parties to conduct appraisals.  Furthermore, the Working Model is now supplemented by two additional documents, “Regulatory Framework for Conducting the Pilot Program within Current Authorities” and the “2019 Test Plan.

The FDA is accepting public comments on the updated Working Model until March 8, 2019.

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About this Author

Svetlana Lyapustina Ph.D. a pharmaceutical scientist with Drinker Biddle
Senior Director, Science, Regulation, & Policy

Svetlana Lyapustina, Ph.D. counsels individual companies and consortia comprised of industry, government and academia representatives on a wide range of topics related to medical product development (pharmaceuticals, medical devices, biologics, and combination products), quality control, manufacturing, regulatory compliance, patient adherence, and regulatory submissions.

Svetlana has represented clients in interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, the Medicines...

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