News & Analysis as of

Innovative Technology › New Guidance › Food and Drug Administration (FDA)

Holland & Knight LLP

FDA Announces Plan to Phase Out Animal Testing Requirement

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

Sheppard Mullin Richter & Hampton LLP on

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Sheppard Mullin Richter & Hampton LLP on

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Hogan Lovells

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

Hogan Lovells on

On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more

Knobbe Martens

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

Knobbe Martens on

The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

7 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide