Trump Proposes to Remove ‘Gender’ References in FDA Regulations

The Food and Drug Administration proposed Tuesday changing its regulations to remove references to gender in order to align ...
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 ...
JD Supra

FDA Announces “RAPID” Pathway for Expedited Access to Breakthrough Devices by Medicare Population

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
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 ...
Becker's Hospital Review

CMS, FDA launch pathway to speed device coverage

CMS FDA launch pathway expedites Medicare coverage for breakthrough medical devices, enabling payment within two months of FDA authorization.
Medical Device and Diagnostic Industry (MD+DI)

The Impact of FDA's Workforce Reduction on Regulatory Timelines for Medical Device Companies

Kezar Life Sciences is a biotech, not a medical device company, but the mechanics work the same way for any company with a ...

FDA Expands Market Access, Authorizes New ENDS Products

With today’s marketing orders, the FDA has now authorized 45 ENDS products for marketing in the U.S. These 45 products are the only ENDS products that may currently be lawfully sold in the U.S. and ...