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The FDA flagged device firms in the U.S., France, Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues. Read More
The Department of Homeland Security issued a warning about two security vulnerabilities in Boston Scientific’s portable cardiac rhythm management systems. Read More
The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions. Read More
Euro-Diagnostics, Kelyniam Global, Magellan Diagnostics and Pelvic Therapies drew warning letters from the FDA for a range of GMP and other failures. Read More
The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from startups to giants in the space. Read More
Moving into 2018, CDRH is focused on two main objectives to change how inspections of medical device manufacturing facilities are conducted — the case for quality and program alignment. Read More
Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for eight violations an FDA investigator observed during an inspection of its Florida facility from March 27 through April 4. Read More