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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
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Read More
The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Read More