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Special Sarasota Breakfast Briefing: "Effective Communication with the FDA"
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FMMC networking and educational event.

1/16/2018
When: January 16, 2018
8:30 AM
Where: ASO LLC
300 Sarasota Center Blvd
Sarasota, Florida  34240
United States
Contact: FMMC
(850) 270-3158


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How to Conduct Effective Communication with the FDA: How (And When) To Get It Right

 

The mere thought of interacting with the FDA causes a great deal of stress for some medical device manufacturers. Right or wrong, the agency has developed a reputation for being less than accommodating and communicative over the years (though there are signs that its chilly demeanor is starting to warm). For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. However, communication with FDA is inevitable, and positive, productive interaction with FDA can make or break your product development efforts - or at the very least accelerate (or impede) your time to market. This session will explore the ideal timing to start engaging the agency, the formal and informal mechanisms for communicating with them, and what I think are the three keys to successful interactions.

Specifically of note, the session will cover the ‘pre-sub’ program - an expansion of the pre-IDE program - which allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program in 2014 and was recently updated (Requests for Feedback on Medical Device Submissions: The Pre-Submission Program, Sept. 2017 available here), many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced. When used effectively, pre-subs can offer significant advantages to the manufacturer by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market.

 

 

Presented by: Michael Drues, Ph.D.

 

Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing, regulatory strategy, intelligence & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

 

Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

 

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.

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