Draft EUDAMED Roadmap of Modules

Draft EUDAMED Roadmap of Modules

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.

FDA’s ASCA Program Becomes Permanent

FDA’s ASCA Program Becomes Permanent

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

FDA Recognizes IEC 60601-1 Edition 3.2

FDA Recognizes IEC 60601-1 Edition 3.2

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