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RTA Policy for 510(k) Submissions

RTA Policy for 510(k) Submissions

by Jack Slovick | Aug 5, 2015 | FDA

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency. The latest RTA...

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510k AIMDD CDRH Draft EAR EN EU Europa European Norm FDA FDIS Food and Drug Administration GUDID ISO ISO/FDIS 9001 IVDD IVDR MDD MDR Medical Device Directive OJEU Quality Management Refuse to Accept RTA UDI

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