​Hi RapsCom, does anybody has information who issues free sales certificates for medical devices in france ? Best regards ------------------------------ Frank Wilmerstaedt General Manager QA/RA ------------------------------

When I get a chance, I'm going to write up a summary of the comments on regulations.gov, but just skimming through them, it seems that the idea of a 10-year cut-off went over like a lead balloon.  The lack of evidence to support FDA's proposals was also cited in a number of comments, and several also thought FDA had it backwards...that "tried and true" ...

Thanks, Maddi.  Software everything is always a mental stretch for me. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ------------------------------

I would replace the old with the new method/validation.  The history will be there in the eCTD backbone.  During development, changes are made to methods, specifications, processes, etc and there is no need to keep all of that history in the current version of each IND section.  That's the beauty of eCTD - the history is always there. ------------------------------ ...

Interesting summary description of who should attend, from a medical device perspective, IMO: Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission as well as globalization, harmonization, and standardization of medical device regulation. Agenda is not yet out, but I'll be interested ...