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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 Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR

Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance has hindered manufacturers’ preparation to ensure they properly address new regulatory expectations by the mandatory conformity dates of May 2020 and May 2022, respectively. Fifteen … Continued

NAMSA® Launches “Uniquely IVD” Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, announced today the launch of its in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” … Continued