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MIVI Neuroscience received a Form 483 with three observations for inadequate corrective and preventive action (CAPA) activities and documentation issues observed during an FDA inspection of the company’s facility in Eden Prairie, Minn., last December. Read More
Companies that market in vitro diagnostic devices (IVDs) in the EU may continue to use existing certificates after the EU’s new In Vitro Diagnostics Regulation (IVDR) goes into effect on May 26 as long as they do not make “significant” changes to the products’ design or intended purposes. Read More
The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices, signaling VIP’s transition from a pilot to a permanent program. Read More
The FDA issued a final guidance explaining its current policy on when agency staff may refuse to consider device companies’ applications for 510(k) clearance of a new product. Read More
The multiplex test will help address increasing rates of sexually transmitted infections (STIs), after disruptions in care during the pandemic contributed to a decline in routine STI screening, the company said. Read More