Provision Consulting GroupOct 24, 20223 minFDA RegulationsFDA Class 1 Medical Devices : UDI RequirementsOctober 24 2022 FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database...
Provision Consulting GroupOct 21, 20225 minFDA RegulationsFDA UDI Guidance of Legacy Identification Number (NDC/NHRIC)October 21 2022 FDA has announced the availability of final guidance entitled “Enforcement Policy Regarding Use of National Health...
Provision Consulting GroupSep 13, 20223 minFDA RegulationsHow Cosmetics are Regulated by FDA?Sep 13 2022 Under the regulation of the FDA, cosmetic products and ingredients do not need FDA premarket approval, with the exception of...
Provision Consulting GroupSep 9, 20223 minFDA RegulationsFDA Medical Device, De Novo Process GuideSep 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...
Provision Consulting GroupSep 8, 20222 minFDA RegulationsFDA Medical Device, overview of 510(k) guideSep 08 2022 The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied...
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...