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Matt Walker

recall advisor
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February 11, 2022
Matt Walker
recall advisor
FDA focuses on women’s health in medical device research and regulation

The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health. The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women…

February 11, 2022 by Matt Walker, recall advisor
Blog
January 03, 2022
Matt Walker
recall advisor
Discovery of benzene in hair care products raises new consumer concerns

Benzene, which has been discovered in several consumer products over the past year, has once again forced a voluntary recall. This time, it’s related to dry shampoo and dry conditioner spray products from various household brands. The recall is prec…

January 03, 2022 by Matt Walker, recall advisor
Blog
December 17, 2021
Matt Walker
recall advisor
New threat modeling playbook prepares medical devices for cybersecurity issues

Cybersecurity has become a critical issue for the medical device industry, where a cyber threat can lead to injury or even death. To address this growing problem, the U.S. Food and Drug Administration, the MITRE Corporation, and the Medical Device In…

December 17, 2021 by Matt Walker, recall advisor
Blog
June 02, 2021
Matt Walker
recall advisor
DOJ increasing enforcement on off-label promotion: Here’s what to expect

We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion. The DOJ and the U…

June 02, 2021 by Matt Walker, recall advisor
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