MobiHealthNews

uChek app is currently FDA registered as Class I device

Following MobiHealthNews' coverage of the rare action that FDA took last week by sending a medical app developer an "It has come to our attention" letter that instructs it to seek 510(k) clearance for ...
RAPS

FDA classifies slew of class II devices following de novo procedures

Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with special controls. The list of devices includes several ...
Regulatory Affairs Professionals Society

MedCon: FDA sees uptick in class I recalls in 2025 as it tackles resourcing issues

The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
WHNT

FDA issues Class 1 recall on tomatoes sold in 3 states, warns of ‘serious adverse health consequences or death’

TENNESSEE (WHNT) — The Federal Drug Administration announced two different tomato recalls affecting 14 states for the possible contamination of Salmonella at the start of May. Both are now classified ...
JD Supra

Call for comments: FDA wants feedback on the distinct classification of existing device accessories into Class I

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
Forbes

Amazon Cookie Recall Now At FDA’s Deadliest Category—Is It A Risk?

The cookie recall affecting Amazon Fresh Jumbo Sugar Cookies has been classified as an FDA Class I recall, the most serious designation. Here’s what consumers need to know. A batch of Amazon Fresh ...
Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
Becker's Hospital Review

FDA issues class-wide labeling changes to testosterone products to include blood pressure, cardiovascular warnings

The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies. The ...