Hogan Lovells Publications | Medical Device Alert | 01 August 2017

FDA unveils software pre-certification pilot program to foster digital health innovation

Following promises in June for a new regulatory paradigm to address regulation of medical software, FDA released a Digital Health Innovation Action Plan on July 27, 2017, including a pilot software Pre-Certification (PreCert) program.

The Digital Health Innovation Action Plan

The Digital Health Innovation Action Plan sketches out details and timelines for FDA’s approach to digital health technology.  The action plan highlights a number of activities that FDA has taken in the past years and months, including releasing the Mobile Medical Apps Guidance, issuing several cybersecurity guidance documents, and working with other government agencies on the FDASIA Health IT Report, among others.  The plan then turns to specific guidance documents that the Agency plans to issue to assist in implementation.

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