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Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

Katten Muchin Rosenman LLP on

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

McDermott Will & Schulte

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Schulte on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

Hogan Lovells on

On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

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