Hogan Lovells Publications | Medical Device Alert | 09 August 2017

FDA’s software Pre-Cert program: More details revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017, webinar to further explain the Pre-Cert program.

The webinar reiterated many of the points covered in the written materials, but further expanded on the scope of the future Pre-Cert program, the goals for the pilot program, and roles for pilot participants. Consistent with the initial program announcement, the webinar emphasized that the Pre-Cert program, once fully developed and implemented, would be designed to streamline the premarket FDA review process for manufacturers of Software as a Medical Device (SaMD) that demonstrate a “Culture of Quality and Organizational Excellence (CQOE).” However, the webinar also made clear that the purpose of the pilot program is to educate FDA and benefits to be realized by pilot participants have not yet been fully defined.

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