FDA Increases Efforts to Flag Public Warnings, Recalls
FDA Commissioner Scott Gottlieb announced last week that the agency is ramping up its efforts to improve public warnings and recall notifications. Read More
TGA Puts New Recall Procedures Into Effect
Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls. Read More
Devices News
U.S. Lawmakers Urge Colleagues to Support Permanent Device Tax Repeal
In a “Dear Colleague” letter last week, a bipartisan group of congressional leaders urged the House to permanently repeal the 2.3 percent medical device tax. Read More
BSI Warns Devicemakers to Migrate CE Certificates Before Brexit Deadline
UK-based standards body BSI warned devicemakers that their CE certificates in the UK could become invalid if the UK and EU fail to negotiate a Brexit deal by March 29. Read More
FDA to Exempt Unclassified Devices From Premarket Notification
The FDA is planning to exempt certain unclassified devices from premarket notification requirements, according to an updated guidance from the agency. Read More
FDA Warns Beverly Hills Surgeon Over Illegal Breast Implant Device
The FDA ordered a Beverly Hills plastic surgeon to stop marketing an implantable pouch that the doctor says can help prevent a nasty side effect for women’s breast augmentations. Read More
