October 21 2022 FDA has announced the availability of final guidance entitled “Enforcement Policy Regarding Use of National Health...

Sep 13 2022 Under the regulation of the FDA, cosmetic products and ingredients do not need FDA premarket approval, with the exception of...

Sep 09 2022 The new device which is a low to medium risk on the market requires a pathway of the De Novo process. The De Novo request...

Sep 08 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...

Sep 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...

Aug 29 2022 All devices are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. This...

Aug 17 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...

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...

Aug 10 2022 The Q-Submission Program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the...

Aug 08 2022 Classification of Medical Devices For your medical device to entrance in the U.S market, classifying your medical device will...