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27 November 2023 The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts
Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments
On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List
June International Regulatory Updates for Canada, Saudi Arabia, EU, & US