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In Law360, Life Sciences and Corporate Team Examines FDA Move to Limit Digital Software Regulations

Practices: Life Sciences, FDA Regulatory, Digital Health

Capital Insights.

A Dec. 21 article published in Law360 examines the U.S. Food and Drug Administration (FDA) latest development to limit digital software regulations. The article was authored by life sciences partner Gregory Levine (Washington, D.C.), associate Abram Barth (New York) and corporate practice associates Rebecca Williams and Sara Bodnar (both of Washington, D.C.)

The authors address two draft guidance documents describing the types of software functions the FDA will not regulate, including clinical and patient decision support software, as well as the FDA adopting final guidance on clinical evaluation of software as a medical device. These actions represent the FDA’s efforts to oversee the digital health products under a risk-based model and prioritize innovation.