IOM Committee Questions Adequacy Of Compliance Tools In 510(k) Program
Questions about the adequacy of FDA's compliance and surveillance tools for 510(k) products were among those raised by an Institute of Medicine task force during its second public meeting to evaluate the pre-market clearance program
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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”