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Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. Read More
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