FDA’s CDRH to expand Digital Health Pre-Cert program

The FDA’s Center for Devices and Radiological Health is looking to expand its digital health pre-certification pilot program by the end of 2018, according to a report from the Regulatory Affairs Professionals Society.

Testing is slated to continue on the pilot program through to December with more participants joining the initial nine selected last December, according to the report.

Despite the expansion, the pilot is still leaving unanswered questions as to how the program should look once it’s complete, CDRH digital health director Bakul Patel said, according to RAPS.

Currently, the ‘pilot’ could be better described as a development program co-created by the FDA alongside industry stakeholders and digital health experts, Patel added.

Patel warned that while the pilot is still in development, if the FDA expands its scope too wide, “we won’t be able to get off the ground,” according to the RAPS report. He asserted that the programs success would be dependent upon whether it was able to create a new regulatory paradigm that aimed to keep pace with digital health’s iterative development nature.

Last July, the FDA revealed its Digital Health Innovation Action plan, including the software Pre-certification Program through which the FDA would shift its regulatory focus from the product to the developers for digital health companies.

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