Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center ...
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH ...
New York, December 03, 2020 -- Moody's Investors Service, ("Moody's") appended an "/LD" designation to CDRH Parent, Inc.'s (dba "Healogics") Caa3-PD Probability of Default Rating (PDR). This reflects ...
The year 2009 is remembered in medtech regulatory circles as the year in which long-simmering turmoil erupted into the open at FDA's Center for Devices and Radiological Health (CDRH). It cost Daniel ...
Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...
William Maisel will retire from the Food and Drug Administration this spring, MedTech Dive has confirmed with the agency. Maisel has been Director of the Office of Product Evaluation and Quality (OPEQ ...
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in ...
In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and ...
In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
At a town hall featuring FDA leadership at the AdvaMed MedTech Conference in Toronto, Michelle Tarver, M.D., Ph.D., took the time to introduce—or reintroduce—herself to members of the industry, this ...
It has taken at least 15 years, but in May, the systemic “corruption” in CDRH's management processes finally got serious attention. Deputy commissioner Joshua Sharfstein ordered an internal, ...
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