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Medical Devices › Regulatory Oversight › Comment Period

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On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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

Goodwin

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

Goodwin on

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

McDermott Will & Schulte

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

McDermott Will & Schulte on

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

Stinson LLP

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Stinson LLP on

On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software.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

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

New draft guidance on MR compatibility for medical devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."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

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

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

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

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

FDA releases working model for Software Precertification Pilot Program

Hogan Lovells on

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more

Hogan Lovells

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

Hogan Lovells on

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive...more

Hogan Lovells

EMA envisage to link development of companion diagnostics and personalised medicines

Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface...more

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