Provision Consulting GroupJun 29, 20222 minFDA RegulationsWhat are the basic MDR requirements from FDA?Jun 29 2022 The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events such as deaths and serious...
Provision Consulting GroupJun 23, 20223 minFDA RegulationsSteps to Get a New Medical Device to MarketJun 23 2022 Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic...
Provision Consulting GroupJun 22, 20223 minFDA RegulationsMedical Device Pathway to FDA ApprovalJun 22 2022 Step 1 Device Discovery and Concept Medical device development follows a well-established path. Many of these steps overlap...
Provision Consulting GroupJun 21, 20223 minFDA RegulationsWhat are the requirements of Quality System FDA Regulation?Jun 21 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
Provision Consulting GroupJun 20, 20225 minFDA RegulationsWhen the De Novo Classification Process May and May Not Be UsedJun 20 2022 In accordance with section 513(f)(2) of the FD&C Act, you may submit a De Novo request for FDA to make a classification...
Provision Consulting GroupJun 17, 20223 minFDA RegulationsFDA Regulation for Importing Medical DeviceJun 17 2022 The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in...