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The association sent a letter to the FDA to enlist the agency’s help in improving the program ahead of next month’s International Medical Device Regulators Forum meeting in Beijing. Read More
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations. Read More
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