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.
JD Supra

FDA Exercises First Use of Import Certification Authority, Establishing New Requirements to Import Shrimp and Spices from Certain Regions in Indonesia

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced that it will begin requiring import certifications for shrimp and all spices from certain regions of Indonesia based on the ...
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 ...
JD Supra

First Appearance of FDA’s Import Certification Authority

The U.S. Food and Drug Administration (FDA) has instituted an import certification requirement for shrimp and spices originating from a specific region of Indonesia. This action follows the detection ...

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 ...
PharmTech

FDA Approval of Cytokinetics’ Myqorzo Reflects Specialty Cardio Drug Trend

From a global regulatory perspective, Cytokinetics is expanding its footprint rapidly. The drug received approval in China on ...
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 ...
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 ...
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 ...
KCUR 89.3 FM

Clay County's food standards are among the best in the country, and fewer people are getting sick

Clay County Public Health Center’s environmental health program has been recognized among the nation's best for food safety. The Food and Drug Administration certification assesses work to ensure ...