CDRH targets hospital readmissions with home device innovation challenge

The Food and Drug Administration’s device center launched an innovation challenge Tuesday to give patients access to home ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA proposes FY27 budget, rejects software petition; and former CDRH leaders launch venture capital fund

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
MedTech Dive

‘Cracks show’ as CDRH staff contend with heavy workloads

Former device leaders said a culture of “fear and anxiety” has driven experienced staff from the Food and Drug Administration ...
WBIW

FDA launches “READI-Home” challenge to accelerate home-based medical tech

The FDA has announced the launch of the READI-Home Innovation Challenge, a new initiative aimed at fast-tracking medical ...
BioPharma Dive

FDA, after turbulent year, leaves drugmakers guessing on its direction

Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator ...

Medline hit with FDA warning letter over angiographic syringe manufacturing failures

An FDA inspection of Medline’s facilities in December 2025 found that the company fell short of certain good manufacturing ...
MedTech Intelligence

FDA Publishes New Set of Real-World Evidence Examples

New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software ...
BioWorld

CDRH will emphasize risk management in CY 2026

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...