The U.S. Food & Drug Administration (FDA) acts as the gatekeeper for commercial sales of medical technology in the U.S. If products fall under the agency’s umbrella, the registration and certification requirements prior to FDA clearance or approval take time and investment. The FDA works to shield consumers from harmful or useless products.
In recognition that the times and health technology are changing, the FDA agency recently announced the Pre-Cert for Software Pilot Program. As part of the agency’s overall Digital Health Innovation Action Plan, the Pre-Cert program allows the FDA to evaluate software developers or digital health technology developers rather than get down to the details of proposed new products. If the software or technology developer meets the as-yet-undetermined pre-certification requirements, the products will be fast-tracked in the FDA process.
Similar to the Department of Homeland Security’s TSA PreCheck approval that lets you waltz through airport security without removing your shoes or taking out your computers (as of the time of this writing), the FDA’s Pre-Cert program is intended to ease passage through a protective mechanism. According to the FDA, the Pre-Certification for Software program has three goals: allowing timely software changes, enabling companies to demonstrate their respective cultures of quality and organizational excellence, and to be a program that self-adjusts based on its effectiveness. In theory, the Pre-Cert program sounds like a good thing. Time and implementation will tell if the promise of expedited software approval will be beneficial to all involved, with the public foremost.
