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FDA Developing Digital Device Certification Process

Stethoscope and iPhone


16 June 2017. The U.S. Food and Drug Administration expects to unveil a new procedure for certifying digital medical devices that the agency says should speed their entry to the market. FDA Commissioner Scott Gottlieb outlined the process yesterday in a blog post on the agency’s web site.

Gottlieb described a new Digital Health Innovation Plan in development by the agency, which he says is needed to foster innovation where medicine and digital technology intersect. One of the reasons for the plan is the exploding number of mobile apps related to health, estimated last year at 165,000, with downloads of these apps predicted to reach 1.7 billion this year. In addition, new software and systems are being developed to help manage medical practices, make diagnoses, offer treatment options, and store and share health records.

He notes that companies making medical devices should have clear guidance from the outset about FDA’s role. “To encourage innovation,” says Gottlieb, “FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”

Part of the new plan, says Gottlieb, will be a third-party certification program designed to help FDA review new digital health products. For lower-risk apps and devices, such as fitness trackers, external certification would replace the agency’s pre-market review. For higher-risk medical devices, certification would provide a mechanism for developers to assess the quality of their products before pre-market review by FDA. Gottlieb gave as an example examination of a company’s software design, testing, and maintenance that could be certified for consistency and reliability, which he said would reduce the time and cost of market entry.

FDA already makes a distinction between low-risk apps and devices for general health and wellness, as reported in Science & Enterprise, and higher-risk systems offering specific diagnostics or treatments, which are subject to oversight. The Digital Health Innovation Plan is also expected to address changes in agency procedures required by the 21st Century Cures Act, passed by Congress and signed by the president in December 2016. Gottlieb says the device certification program will be unveiled in the fall of 2017.

Gottlieb wants as well to make greater use of third-party data analysis services in post-market evaluations of digital medical devices. FDA is setting up a National Evaluation System for health Technology, or NEST, to collect real-world evidence of device performance from electronic health records, insurance claims, patient registries, and other sources. The agency expects to announce in the next few weeks a governing council for NEST at the Medical Device Innovation Consortium, a not-for-profit organization founded in 2012 with representatives from industry, government agencies (including FDA), and other not-for-profits. NEST is expected to be fully operational in 2019.

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