FoodNavigator-USA

Why the FDA is revisiting gluten disclosure

FDA requests information to explore whether current gluten labeling rules adequately protect consumers, with implications for ...
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.
JD Supra

FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies

On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the ...
Android

Apple Watch series AFib monitor getting FDA medical certification

The Apple Watch series AFib feature has received new approval from the FDA. From now on, the results returned by the devices are considered medical grade. Previously, the results could be considered ...
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 ...
Becker's Hospital Review

Senate Democrats question if FDA’s digital health pre-certification will ‘compromise public safety’

Three Democratic senators are requesting additional information about the FDA’s Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...
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 ...
Supermarket News

FDA OKS MORE MEXICAN CANTALOUPES

NOGALES, Ariz. -- The Food and Drug Administration last week approved another Mexican cantaloupe grower to ship product to the United States, giving retailers here an additional, close-by source as ...
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 Insider

Dr. Harvey Karp planned to tell the press the $1,700 Snoo was 'proven to reduce SIDS' last summer. But the FDA stamp of approval never came.

Dr. Harvey Karp nearly announced last summer that the FDA certified that Snoo reduces SIDS. But FDA approval of the $1,700 high-tech crib never came — and month's later is still missing. Experts say ...