New FDA draft guidance formally acknowledges device-embedded age-gating technology in PMTA review for the first time, signalling the important role that technology and innovation can play in ...

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 ...

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 ...

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 ...

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

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

Many medical devices need to be sterile to be used safely. But sterilizing a pacemaker, catheter, or other device with steam or heat could damage its structural integrity. So medical device ...

(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 ...

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 ...

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