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FDA Announces FY19 User Fees

Today, the U.S. Food & Drug Administration (FDA) published its User Fees for Fiscal Year 2019 (October 1, 2018 – September 30, 2019), which includes pricing for device submissions and establishment registrations. The official notice from the FDA may be found by clicking here. The most significant changes for U.S. medical device manufacturers to consider are … Continued

EU MDR and IVDR Compliance Planning Resources

The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and … Continued