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Holland & Knight LLP

New FDA Digital Health Program

Holland & Knight LLP on

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more

McDermott Will & Emery

US Food and Drug Administration’s New Digital Health Innovation Action Plan Details a Software Precertification Pilot Program

McDermott Will & Emery on

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more

Mintz - Health Care Viewpoints

FDA Releases Revised Guidance on Device Modification Policy

Mintz - Health Care Viewpoints on

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

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