Provision Consulting GroupSep 1, 20231 minFDA Regulations[FDA News] Webinar on September 12 - Qualification of Medical Device Development ToolsThe U.S. Food and Drug Administration (FDA) is scheduled to hold a webinar on September 12, 2023. This webinar is intended for industry...
Provision Consulting GroupAug 14, 20233 minFDA Regulations[FDA MoCRA Special Contribution #1] What is MoCRA? Brief IntroductionAfter 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29,...
Provision Consulting GroupJul 31, 20232 minFDA RegulationsFDA, FY 2024 Medical Device User Fees NoticeOn July 28, 2023, the U.S. Food and Drug Administration (FDA) announced the Medical Device User Fee for Fiscal Year 2024 (FY 2024). This...
Provision Consulting GroupJul 17, 20232 minFDA Regulations[FDA News] Do Not Use RoyalVibe Health, CellQuicken or ...Ultrasound Medical DevicesOn July 17th, the U.S. Food and Drug Administration (FDA) announced a ban on the use of ultrasound medical devices manufactured and...
Provision Consulting GroupJul 3, 20232 minFDA Regulations[FDA News] eMDR System EnhancementsOn June 30, 2023, the FDA announced the enhancements to the Electronic Medical Device Reporting (eMDR) system. While the FDA eSubmitter...
Provision Consulting GroupJul 3, 20233 minFDA RegulationsWhat are MDR and eMDR?What is MDR? MDR stands for Medical Device Reporting. It refers to the requirement outlined in 21 CFR Part 803, which mandates...