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

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 ...
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 ...
Fleet Owner

FDA: New certification body LSQA in third-party program

The ANSI-ASQ National Accreditation Board (ANAB) recently notified the US Food and Drug Administration that LSQA SA of Montevideo, Uruguay now is accredited as a certification body (CB) by ANAB under ...
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 ...
FOX8 Cleveland

Local company gets FDA certification for gloves protecting against fentanyl

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. MINERVA, Ohio (WJW) – A local company has ...
Fierce Healthcare

Sen. Elizabeth Warren, top Democrats continue scrutiny of FDA's pre-certification pilot for digital health

Three Democratic senators, led by presidential candidate Sen. Elizabeth Warren (D-Mass), are again raising concerns about the U.S. Food and Drug Administration's Software Pre-Certification program, ...
The Manila Times

Best NMN Supplement Standards: GenuinePurity Establishes Certificate of Authenticity and 96% Purity Verification After FDA Confirms Lawful Status

Leading Edge Health's GenuinePurity brand addresses authentication challenges and bioavailability concerns with certificate ...
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 ...
Nasdaq

Optec Applies for CLIA Certification as FDA Opens Door to Widespread Home Use of Antigen Rapid Tests

CARLSBAD, CA / ACCESSWIRE / April 8, 2021 / OPTEC International, Inc. (OTC Pink:OPTI), a developer of UV and UV-C safety products using related advanced technologies specific to Personal Protection ...