We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More
The FDA has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
In an acquisition worth up to $860 million, Covidien is integrating Israeli gastrointestinal devicemaker Given Imaging into its medical device business. Read More