FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and ...

Welcome to Week 2 of This Week at FDA. We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the Federal ...

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

The U.S. Food and Drug Administration (FDA) has launched the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge to accelerate patient access to medical devi ...

New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.

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

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

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 ...

A small FDA survey of nine hospitals found that the most popular use cases for RFID (radio frequency identification) technology are infusion pumps, portable monitors, wheelchairs, beds, and ...

The CDRH aims to reduce readmissions using technologies that support patients and caregivers after a hospital stay. ...