FDA Selects Apple, Roche, J&J and Others for Digital Health PilotBy
The US Food and Drug Administration (FDA) has selected nine companies to participate in a pilot program for digital-health regulation in the US, called the Digital Health Software Precertification Pilot Program (FDA Pre-cert). Participating companies include: Apple, Roche, Johnson & Johnson, Pear Therapeutics, Phosphorus, Fitbit, Samsung, Tidepool, and Google’s Verily.
The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital-health technology by looking at the software developer or digital-health technology developer, rather than primarily at the product. “The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify the company,” the FDA said in launching the pilot. “With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program.The FDA is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for premarket review in some cases,” the FDA said.
The FDA launched the Pre-cert pilot program in July 2017 as part of the agency’s Digital Health Innovation Action Plan. The plan outlines the agency’s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (The 21st Century Cures Act), adding expertise to the digital-health unit, and initiating the FDA Pre-cert pilot program.
In selecting the participants, the agency considered several factors, including company size, demonstrated record of quality and organizational excellence, clinical focus area, and the risk profile of the product.