RAPS

FDA should establish a public database of device labels, experts say

The US Food and Drug Administration (FDA) should establish a public database of medical device labels that is accessible to patients, healthcare providers, and consumers. This database would help ...
FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
California Healthline

Lawmakers Ask FDA To Alter Device Safety Databases

On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
MD&M East

Database System to Boost FDA’s Postmarket Surveillance Capability

(click to enlarge)A potential organizational structure for FDA's Sentinel initiative. It can take a long time for FDA to piece together medical device reports (MDRs) and other data to determine that ...
STAT

FDA warns medical device makers about rise in fabricated data

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by ...
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 ...
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
MedPage Today

FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday. The HeartMate 3 is considered the safest ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.