Provision Consulting GroupSep 1, 20222 minFDA RegulationsFDA Regulatory of Hearing AidsSep 01 2022 On August 16, 2022, The U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in...
Provision Consulting GroupAug 29, 20223 minFDA RegulationsWhat are the basic FDA requirements of Unique Device Identification(UDI) System ?Aug 29 2022 All devices are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. This...
Provision Consulting GroupAug 17, 20222 minFDA RegulationsFDA Medical Device, overview of 510(k) guideAug 17 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
Provision Consulting GroupAug 11, 20222 minFDA RegulationsFDA Guidance of OTC Drug Aug 11 2022 To market OTC Drug products in the U.S, There are two pathways which is submitting a New Drug Application (NDA) for FDA...
Provision Consulting GroupAug 10, 20223 minFDA RegulationsFDA Medical Device Q-Submission : Preparation and ReviewAug 10 2022 The Q-Submission Program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the...
Provision Consulting GroupAug 8, 20224 minFDA RegulationsFDA Medical Device : Determining your path to U.S marketAug 08 2022 Classification of Medical Devices For your medical device to entrance in the U.S market, classifying your medical device will...