Publications

Hogan Lovells Publications

De Novo requests: FDA releases updated RTA checklist Medical Device Alert

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."

Hogan Lovells Publications

CDRH issues final rule on appeals, excluding De Novos from 517A Medical Device Alert

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two...

Hogan Lovells Publications

An intelligent approach for regulating medical device AI Medical Device Alert

Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device (SaMD) products and other medical...

Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization Medical Device Alert

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

Hogan Lovells Publications

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications Medical Device Alert

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers Medical Device Alert

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

Hogan Lovells Publications

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices Medical Device Alert

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...

Hogan Lovells Publications

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions Medical Device Alert

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain...

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