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Pharmaceutical Industry › Food and Drug Administration (FDA) › De Novo Standard of Review

Akin Gump Strauss Hauer & Feld LLP

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

Akin Gump Strauss Hauer & Feld LLP on

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

Hogan Lovells

De Novo requests: FDA releases updated RTA checklist

Hogan Lovells on

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests." ...more

Mintz - Health Care Viewpoints

Device Modernization Series: In Vitro Clinical Tests

Mintz - Health Care Viewpoints on

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more

Dorsey & Whitney LLP

FDA Testing New Approaches for Review of Digital Health Device Applications

Dorsey & Whitney LLP on

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Wilson Sonsini Goodrich & Rosati

FDA Joint Statement Is a Harbinger of Significant Change for the 510(k) Program

Wilson Sonsini Goodrich & Rosati on

Background: The Increasing Regulation of Medical Devices Subject to 510(k) Clearance - The U.S. Food and Drug Administration's (FDA's) 510(k) premarket clearance pathway is the road to commercialization for thousands of...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

Mintz - Health Care Viewpoints on

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

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