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FDA Announces FY 2018 MDUFA Fees

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments...
Transitioning to ISO 13485:2016

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach....