FDA seeks to regulate digital health software

The Food and Drug Administration is establishing protocols — and a new digital health unit — to better regulate digital health software, reports Regulatory Focus.

The effort started last October, when the FDA released draft guidance on classifying software as a medical device. Now, the agency is sorting through the nearly 1,400 comments it received on the guidance, Bakul Patel, ‎the FDA's associate center director for digital health, said May 4 at the MedCon conference in Cincinnati.

Mr. Patel said the FDA is discussing "what clinical validation looks like for software" and cited the difficulty of regulating such rapidly evolving software programs, according to Regulatory Focus.

The FDA is also creating a new digital health unit within the Center for Devices and Radiological Health to explore regulatory pathways tailored for digital health technology that relies on real world evidence, according to the report.

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