Duration: 60 Minutes
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying the factors and use of related criteria provides a credible basis on which to determine the safety and effectiveness of the software. Using such software requires careful evaluation in terms of its design performance, reliability, and clinical validation. With that in mind, the FDA issued a draft guidance on October 14, 2016, that brings the FDA into greater harmony with international voluntary standards concerning the clinical evaluation of SaMD.
SaMD applications can range from the simple, e.g., electronic health records, to the extraordinary complex, e.g., for the treatment or diagnosis of critical care patients. The principles in the document establish uniform criteria and factors for the evaluation of SaMD. The FDA’s Quality Systems regulation and Total Product Life Cycle (TPCL) paradigm still apply as a domestic regulatory matter, but the guidance takes all software developers, domestic and foreign, onto a level playing field for establishing a credible level to support reliance on SaMD.
The draft guidance, in effect, is the FDA’s incorporation of the International Medical Device Regulators Forum’s (IMDRF) proposed document, which puts forth design level clinical evaluation criteria for the development and application of SaMD. The document is intended to provide global evaluation tools. In some manner, this may create greater confidence in the design and use of SaMD as part of larger global harmonization process for medical devices. Other software related software issues, such as interoperability and cybersecurity are not addressed in the guidance, but for U.S. purposes, those factors warrant consideration to determine usability of SaMD under normal conditions of use.
The draft document creates another step toward the global harmonization for medical product regulation. In keeping with an implementation of the IMDRF document, the FDA will likely look for SaMS evaluation criteria in original software designs and design change. The draft guidance is relatively complex, so it will take time for software developers and manufacturers to incorporate the guidance into its existing premarket and postmarket procedures.
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