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The (draft) guidance is now available at : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-biocompatibility-certain-devices-contact-intact-skin . With kindest regards, ------------------------------ Ary Saaman Director, Regulatory Affairs Lausanne Switzerland ...

Also have a look at 21 CFR 808 : EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS. With kindest regards,  ------------------------------ Ary Saaman Director, Regulatory Affairs Lausanne Switzerland ------------------------------

April - whereas your message does not provide a lot of information about your devices, we find the below reference very useful. With kindest regards,  VDI 2017 - Medical Grade Plastics (MGP) - July 2019 (bilingual German/English) [VDI = Verein Deutscher Ingenieure, the German Association ...

Have a look at AAMI TIR48:2015 "Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products". With kindest regards, ------------------------------ Ary Saaman Director, Regulatory Affairs Lausanne Switzerland ------------------- ...

In addition to my above post, see also the following blog by Erik Vollebregt about the proposal for delaying the EU MDR's DoA  till May 26, 2021. https://medicaldeviceslegal.com/2020/04/08/mdr-amendment-proposal-article-120-3-oversight-set-to-be-fixed-by-council/ Stay safe and all the best, ...