FDA Plans to Exempt Some Health Software From Device Rules

The FDA plans to encourage innovation by lightening the regulatory load on manufacturers of digital health-care devices and software in upcoming months.

Certain types of clinical decision support software (CDS), for example, would be exempt from the Food and Drug Administration’s regulation, according to one draft guidance.

The second draft guidance would detail certain digital health devices, including mobile health apps, that the FDA wouldn’t consider medical devices and thus wouldn’t regulate.

The two draft guidance documents were issued to provide a greater clarity to manufacturers about which software the FDA will—and won’t—regulate following the passage of the 21st ...