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Food and Drug Administration (FDA) › Digital Health › 21st Century Cures Initiative

Fenwick & West Life Sciences Group

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

Fenwick & West Life Sciences Group on

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

Hogan Lovells

FDA’s Software Pre-Cert Program: More Details Revealed

Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

Morgan Lewis

The 21st Century Cures Act and Its Effect on Digital Health

Morgan Lewis on

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

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