Hoggan Scientific LLC has been hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues. Read More
Australia’s regulator outlined a new priority review pathway for medical devices and is asking industry for feedback on its proposal. Read More
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More
The UK’s Medicines and Healthcare products Regulatory Agency released urgent recall notices for a range of medical devices, including Smith & Nephew’s Reflection dead blow mallet, Roche’s neonatal cobas test, Acutronic’s neonatal ventila... Read More
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