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FDA Warning Letter Recap

Feedback Sought On Proposals To Improve Australia’s Recall Processes

The deadline is nearing for comments on changes the Therapeutic Goods Administration has proposed making to its therapeutic products recall processes.

Recalls Australia

Warning Letters And Close-Outs – February 2023

The US FDA released three device-related closeout letters in February, resolving past citations against BioModeling Solutions, Sooil Development Co., and USA Medical LLC. No new warning letters were issued.

Regulation Medical Device

News We’re Watching – Medicare Covers Dexcom CGM; New Mpox EUA; $106M Patent Verdict Against Medtronic

Medicare announced coverage for the Dexcom G7 continuous glucose monitor, as well as a breast cancer indication for Natera Inc.’s Signatera; the FDA authorized a new monkeypox test; the FDA issued a warning letter to a Texas masks firm; and a new report says NIST labs are failing behind. 

Regulation Policy

Warning Letter Close-Outs – January 2023

The US FDA released only one device-related close-out letters in January which went to a Michigan orthopedics firm.

Regulation Warning Letters

Warning Letter Roundup & Recap – January 2023

The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.

Regulation FDA

FDA Issues Back-To-Back Warnings To Major Endoscope Maker Amid Device Reporting And Quality Systems Concerns

The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.

FDA Policy

Texas OTC Medtech Firm Refuses FDA Inspection, Continues Selling Unapproved Products

RoyalVibe Health makes and sells unapproved devices in kits and individually “intended for the diagnosis and treatment of several diseases including but not limited to cancer, Alzheimer’s, ischemic stroke, arthritis, and type 1 diabetes,” FDA warning states.

Warning Letters FDA

Warning Letter Roundup & Recap – December 2022

The US Food and Drug Administration published two device-related warning letters in December, both of which went to marketers of products not authorized by the agency.

Warning Letters FDA

Warning Letter Close-Outs – December 2022

The US FDA released only one device-related close-out letters in December, which went to the maker of a tray used to flash sterilize devices. 

Enforcement Regulation

Warning Letter Close-Outs – November 2022

The US FDA released three device-related close-out letters in November, all of which related to premarket conduct.

Warning Letters FDA

Warning Letter Roundup & Recap – November 2022

The US Food and Drug Administration published only one device-related warning letter last month. It went to an Illinois clinical trial site.

Warning Letters Clinical Trials

FDA Warns Eye Care Company Conducting Unapproved Clinical Trial Of Drug-Device Product

The FDA sent a warning letter to Arbor Center for EyeCare for failing to submit an IND before beginning a trial of a novel drug-device combination product.

Warning Letters Regulation
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