The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continued its proactive approach to regulating standalone AI medical devices (AIaMD) with Thursday’s launch of its AI Airlock sandbox model, allowing…
The FDA’s recent Warning Letter to Augustine Temperature Management focused on a single — issue problems with medical device reporting (MDR) — citing the Bloomington, Minn.,-based company for multiple failures…
This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during a Section 564 declared emergency, IVD enforcement policy…
The Department of Justice (DOJ) has formed a new enforcement arm — the Task Force Health Care Monopolies and Collusion (HCMC) — to guide the department’s policy approach for healthcare,…
The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically modified organisms and biotechnology products for humans.…
Concerns about unexpected shutdown leading to possible injury and/or death has caused the FDA to issue an alert about several cardiac devices manufactured by Getinge/Datascope/Maquet. Source: Drug Industry Daily
A mobile app that controls an insulin pump has been recalled for a software problem that potentially leads to crash of the app and pump battery depletion. Source: Drug Industry…
Clarity on the definition of “remanufacturing” for reusable medical devices needing maintenance or repair is the focus of a final guidance the FDA issued on Thursday. Source: Drug Industry Daily
The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation especially for terms involving real world data (RWD) and real…
A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues across all products areas, were included in the FDA’s FY…