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  • I concur with Ginger's feedback. I've used a new minor change, one that wouldn't normally trigger a new 510(k), as the basis of filing a new 510(k) that allowed the company to "catch up" with the incremental changes over the years and establish a new base 510(k). Julie ------------------------------ Julie Broderick RAC Principal/Consultant Broderick...

  • A set of planned "fence posts" for a study is fine during a pre-submission. Since you have the opportunity to specify questions in a pre-submission, I would suggest asking the FDA to comment on your outline with regards to the statistical aspects as well. ------------------------------ Michael Nilo Network Regulatory Partners Nilo Medical Consulting...

  • Hello everyone, In conjunction with the meeting of IMDRF in Vancouver, DITTA is hosting a workshop on Monday March 13 th - Exploring the Medical Device Single Audit Program (MDSAP). Registration is now open - http://globalditta.org/register/ . ------------------------------ Dinar Suleman RAC Manager, Regulatory Affairs Lifescan Canada,...

Speaking at Convergence

"In speaking, I seek the satisfaction that comes from knowing I have made a positive impact on someone's career. Plus, I feel that speaking allows me to shape the development of future RA speakers. People will watch our presentation style and learn from it, in the same way I do. Our presentation content and style evolves and it is very important to listen to the participant's feedback to adjust our content and our style." 

Nicole Landreville, PEng, RAC, FRAPS. 


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