WEBINAR: Conducting Effective FDA Pre-Sub Meetings: Tell, Don’t Ask… Lead, Don’t Follow!

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable!

May 23, 2018

The ‘pre-sub’ program – an expansion of the pre-IDE program – 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 then updated in 2017, 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. Join Michael Drues, Ph.D., president of Vascular Sciences, for a webinar designed to enhance communication with FDA.

Conducting Effective FDA Pre-Sub Meetings: Tell, Don’t Ask… Lead, Don’t Follow! 
Free webinar available to AABME subscribers only.
Tuesday, June 19
11 AM - 12 PM EDT

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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. This presentation will use the case study approach to present the pre-sub process in an interactive fashion including:

  • When should the pre-sub process be used and when should it not be?
  • How does the process work and what can the manufacturer expect?
  • When is it better to meet formally or informally? Should you meet in person or via teleconference?
  • What info should be provided in advance and what should be provided at the meeting?
  • What happens after the meeting? How should the manufacturer follow-up? Are the results binding?
  • Are there other ways to communicate with FDA beyond pre-subs and when should they be used?

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About the presenter:

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 educational programing, regulatory strategy and regulatory 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. 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.

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.

Finally, Dr. Drues is an adjunct professor of medicine, biomedical engineering & biotechnology at several universities and medical schools. He regularly teaches graduate courses in regulatory affairs and clinical trials, clinical trial design, medical device regulatory affairs and product development, combination products, pathophysiology, medical technology, translational medicine and biotechnology.