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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 to adequately develop, maintain and implement written MDR procedures. Read More
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, but also to pursue investigations as well as civil and criminal enforcement in healthcare. Read More
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. Read More
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. Read More
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. Read More
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 world evidence (RWE). Read More
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 2025 budget proposed to a Senate Appropriations subcommittee Wednesday morning by Commissioner Robert Califf. Read More
The United Kingdom’s medicines and medical devices regulator has unveiled its approach to AI in a report presented to the UK government, urging transparency, inclusivity and aligning with partners globally among its key published principles. Read More
Five EU regulatory authorities have published a joint plan to support the implementation of the One Health agenda in the EU, a plan help prevent and respond to health threats. Read More