From creating product codes to following regulations, do you ever wonder what goes on inside the U.S. Food and Drug Administration (FDA)?
In this episode, Allison Komiyama of Acknowledge Regulatory Strategies is a former FDA reviewer and she shares with listeners some fun facts about the FDA and what we don’t see behind closed doors.
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“FDA is moving towards being very open to collaborate with industry and also coming up with new programs that are really beneficial.”
“A lot of companies are getting sort of sent down the De Novo Pathway, when there actually might be another pathway...approach FDA to generate a new product code.”
“How do we actually work with FDA? We all, at the end of the day, want to help patients. We all want to get the best device on the market.”
“Companies don’t want to touch the patient population for pediatrics with a 10-foot pole. If you hurt a kid with your device...that’s really bad for your company.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...