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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
The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI
After a delay of over a year since the original US Technical Advisory Group IEC/SC62A & specific technical committees — Electrical Safety, Electromagnetic Compatibility, Alarms, and Home Care and EMS Environments committees — vote and an additional vote for each of
Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.