The FDA did something good for digital health — even skeptics agree FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare!!

FDA announced a pilot program that might result in a “pre-certification” for digital health startups. That would provide some much-needed clarity for digital health startups, and a potential fast-track to get a green-light from regulators. This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.

FDA’s Center for Devices and Radiological Health (CDRH) is publishing its Digital Health Innovation Action Plan to provide details and timelines for our integrated approach to digital health technology and the implementation of the 21st Century Cures Act. The voluntary pilot program will enable FDA to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based pre-certification program for these new tools.

The goal of our new approach is to determine whether the company meets the necessary quality standards and pre-certify the company. Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a premarket submission at all.

The initiative will begin immediately. Starting on August 1, companies can request participation in the pilot to FDAPre-CertPilot@fda.hhs.gov. This can help people better manage their chronic diseases, which could result in less trips to the doctor for checkups, or better awareness of illness, like prompts to a parent with a sick child on when they need to see a provider.

For more information on the project please visit FDA Voice by Commissioner Scott Gottlieb, M.D.

 

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