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The FDA handed a warning letter to Anigan for numerous GMP violations it uncovered during an April 2018 inspection of the firm’s San Ramon, California facility. Read More
The FDA issued guidance for small businesses seeking a discount on medical device application user fees or a waiver for a first premarket application fee and began accepting small business certification requests for fiscal 2019 on Aug. 1. Read More
The HPRA directed users of the kits to check for a European address on the packaging – which should not be damaged – and the CE Mark, along with its four digit number. In addition, it cautioned that the kits are not appropriate for patients already diagnosed with the virus or for those taking PrEP. Read More
Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1, 2019. Read More
The FDA released new draft guidance for devicemakers on submitting premarket notifications for metal expandable biliary stents and their delivery systems. Read More
IMDRF’s Adverse Event Terminology Working Group is seeking comments on proposals to harmonize terminology globally for reporting adverse events for medical devices and in vitro diagnostics. Read More
Bayer announced it would stop selling its Essure permanent birth control device after Dec. 31 and the FDA said it expects the company to meet its postmarket obligations. Read More
Brazil released its first requirements for unique device identifiers for high-risk medical devices that are slated to go into effect in 2020. Read More