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The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related analysis off the market. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
A federal panel is recommending that the FDA retain regulatory authority over high-risk device software, while loosening regulations around two categories considered to be lower risk. Read More
Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. Read More
The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design. Read More
“Accurate detection … is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer,” Cepheid CEO John Bishop says. Read More
A new FDA report shows medical device recalls nearly doubled from fiscal year 2003 to 2013, but a greater focus on safety — not shoddier products — appears to be behind the rise. Read More
The FDA last month approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More
Abbott Vascular received an FDA Form 483 because its Temecula, Calif., facility did not have a procedure defining storage conditions for certain biological indicators. Read More