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The rejection “reflects the agency’s belief that the current processes in place at servicing facilities support continued quality, safety, and effectiveness of medical devices that undergo servicing,” the agency said. Read More
Clinical trial sponsors must step up their efforts to address underrepresentation of women among subjects in clinical trials, including for medical devices, said FDA Commissioner Scott Gottlieb during a meeting to commemorate National Women’s Health Week. Read More
Industry leaders are calling on Congress to modernize legislation covering clinical laboratory diagnostics to bring it into the 21st Century. Read More
The final guidance omits language from a draft document that said the regulatory authority “does not dictate how a manufacturer should prove that their medical devices have met the essential principles.” Read More
New Zealand’s Medicines and Medical Devices Safety Authority is proposing fee increases for the majority of its services, including reviewing new devices and GMP inspections. Read More
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple function devices. Read More