NEWS

FDA Moves Forward with Pre-Cert Program for Digital Health Devices

January 11, 2019

The US Food and Drug Administration (FDA) announced plans it hopes will lead to greater efficiency in its review of digital health technologies under its Digital Health Precertification (Pre-Cert) Program.

Apple, Fitbit, and 7 other companies are participating in the Pre-Cert pilot program.

“Our aim has been to develop a Pre-Cert program that would allow developers who have been assessed by the FDA for meeting specific excellence principles—known as an ‘Excellence Appraisal’—to participate in a more tailored premarket submission process appropriate for their specific type of digital device,” said Scott Gottlieb, MD, FDA commissioner, in a January 7, 2019, statement.

The Pre-Cert Program’s Excellence Appraisal guidelines are geared to streamline developers’ Quality System Regulation requirements under the traditional De Novo regulatory pathway. 

“By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo submission, reducing content the developer would need to submit to the agency under the De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal,” Dr Gottlieb said. “This allows the FDA to tailor the premarket submission content to the unique considerations related to each particular digital health device and enables more efficient evaluation of low-risk digital health devices.”

The FDA also announced it intends to use two parallel review processes in 2019: the Pre-Cert pathway model and the traditional De Novo pathway model. The set-up will allow the agency to compare the effectiveness and efficiency of the two processes.

“[W]e will review the sponsor’s traditional De Novo submission for its device and using that same submission information we will, in parallel, review the sponsor’s Excellence Appraisal information with the proposed streamlined submission content,” Dr Gottlieb explained.

“[T]his approach will help the FDA show that the combined assurance resulting from the proposed Excellence Appraisal and streamlined premarket review submission will provide the same quality and type of information necessary … compared to the FDA’s approach in reviewing these devices under the traditional De Novo review process.”

Jolynn Tumolo


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