GlobalData on MSN

LifeVac receives FDA De Novo classification for anti-choking device

LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

Veristat Expands Regulatory and Clinical Services to Chinese Drug and Device Companies Seeking Efficient Way to Enter European Markets

Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced expanded regulatory and clinical trial services to international pharmaceutical and ...
JD Supra

Navigating Medical Device Regulation and IP Protection in the United States (Part 2 of 2)

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...
JD Supra

Drug and Medical Device Regulation Under the Trump Administration

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
STAT

FDA grants ‘breakthrough’ status to generative AI chatbot for surgical patients

The FDA's decision on a chatbot for patients recovering from surgery could offer clues on how the agency plans to regulate ...

Cognita secures FDA breakthrough device designation for CXR

Mosaic expects the collaboration with the FDA will help address diagnostic capacity constraints in the US healthcare system.
MD&M East

FDA Staff Cuts & Global Tariffs Pose Challenges for Medical Device Development, Experts Warn

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
MobiHealthNews

How to avoid FDA mHealth regulation

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...