The Pre-Cert for Software Pilot Program — a part of the FDA’s Digital Health Innovation Action Plan — would enable the FDA to streamline approvals for digital health technologies by reviewing developers rather than their individual products. Pre-certified companies would be able to launch their technologies and collect post-market data, which the FDA would use to assure product safety and effectiveness, Dr. Gottlieb wrote.
The agency will evaluate companies based on software design, validation and maintenance to determine whether or not they meet certain quality standards. For consideration in the pilot, companies must be in the process of developing or planning a new medical device software. Companies also must demonstrate a track record of developing, testing and maintaining software products, measured by the program’s key performance indicators.
Dr. Gottlieb wrote he expects the first four months of the pilot to help the FDA’s regulatory team as well as product developers improve development programs.
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