Regulatory Oversight, Comment Period, Medical Devices

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

Katten Muchin Rosenman LLP on 6/30/2025

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

Goodwin on 10/9/2023

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Schulte on 10/17/2019

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Stinson LLP on 10/16/2019

On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Schulte on 8/28/2019

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

New draft guidance on MR compatibility for medical devices

Hogan Lovells on 8/13/2019

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

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

Hogan Lovells on 8/8/2019

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

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on 4/11/2019

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

Hogan Lovells on 11/27/2018

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

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