Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.
MobiHealthNews

FDA opens applications for digital health pre-certification pilot program

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr.
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

OnePlus seeks FDA approval for Sleep Apnea Detection on its watch and takes on Apple in the process

OnePlus is looking for FDA approval for its Sleep Apnea detection feature The OnePlus Watch 3 launched without FDA ...
Morningstar

FDA to Require Certification on Shrimp, Spices After Radioactive Contamination

The Food and Drug Administration said Friday it will now require import certification for shrimp and spices from certain regions of Indonesia following a bout of shrimp recalls related to radioactive ...
Fox2Now St. Louis

Gummi World Makes History: First U.S. Gummy Manufacturer to Earn Over-the-Counter Drug Certification

Breakthrough OTC 455-4 Certification Positions Gummi World as the First Pharmaceutical-Grade Gummy Partner in the U.S. CHANDLER, AZ / ACCESS Newswire / June 12, 2025 / Gummi World, a wholly owned ...
Business Wire

Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness

AUSTIN, Texas--(BUSINESS WIRE)--Lumaegis, Inc., an emerging leader in medical device innovation, was recently honored as one of the 2024 RadLaunch Challenge Winners by the International Ultraviolet ...
The Times of Houma/Thibodaux

Five certified shrimp processors attempted to export antibiotic-contaminated shrimp to the United States in November; FDA reports.

The FDA has now refused a total of 91 entry lines of imported shrimp for drug residues through November 2025-- the most since 2016.
Morningstar

Gummi World Makes History: First U.S. Gummy Manufacturer to Earn Over-the-Counter Drug Certification

This OTC certification marks the first of several expansions planned for 2025 as the company evolves into a full-scale pharmaceutical-grade contract partner, positioned to lead the market in ...