Medical Device Premarket Regulatory Pathways - Webinar CD/Transcript

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Medical Device Premarket Regulatory Pathways: Maximizing Efficiency—Saving Time, Money & Resources

The premarket approval process is complicated enough, add in the Cures Act and you need a little help following the best route.

It doesn’t involve the usual mechanisms — IDE, PMA, 510(k) — but rather, taking advantage of provisions tucked within the 21st Century Cures Act, and proposed Medical Device User Fee Amendments (MDUFA) IV goals. A business-friendly White House helps things along.

FDAnews has called on two leading NSF Health Sciences consultants to guide devicemakers like you through the twists and the turns.

You’ll discover:

  • How to sort through the FDA feedback process — early feasibility/first-in-human and expedited-access pathways, de novo classification process, pre-submissions and more
  • Where and how to get precious regulatory information on your product classification
  • How to focus communications with the FDA to direct your products to the best premarket pathways
  • The game-changers lurking within the 21st Century Cure Act and pending MDUFA goals
  • When and how to take advantage of them: A chalk talk
  • And much more!

Your presenters boast a wealth of premarket-approval experience. Caroline Rhim Ph.D. was Branch Chief-Anterior Spinal Devices, Office of Device Evaluation, CDRH, with deep experience involving premarket submission of novel orthopedic and cardiovascular devices. Meaghan Bailey RAC is an expert on preparing sponsors for Medical Devices Advisory Committee meetings and other premarket FDA interactions, and has been involved with premarket approval of in vitro diagnostics, and devices to treat and manage women’s health and diabetes.

Speedier, smoother premarket approvals spell huge cost savings — millions, perhaps — plus greater profits as you bring your products to market sooner. Discover how to make it happen and get the drop on competitors.

  • CEO/COO/CFO/CMO
  • Regulatory Affairs
  • Quality
  • Marketing/Sales
  • Product Management
  • Clinical and Medical Affairs
  • Reimbursement
  • Market access
  • Government affairs

Meet Your Presenters

Caroline Rhim Ph.D., Executive Director, Medical Device Consulting, NSF Health Sciences, comes to the private sector following service as Branch Chief-Anterior Spinal Devices, Office of Device Evaluation, CDRH. At the FDA she also played a central role in streamlining premarket and postmarket review processes, as well as classification efforts for posterior cervical screw systems. She has deep regulatory experience involving premarket submission of novel orthopedic and cardiovascular devices.

Meaghan Bailey RAC, Managing Director-Device Consulting, NSF Health Sciences. Meaghan Bailey advises life science companies on regulatory strategies, prepares regulatory submissions, conducts literature reviews and other analyses, and provides assistance with preclinical and clinical programs. She is an expert on preparing sponsors for Medical Devices Advisory Committee panel meetings and other premarket FDA interactions; and has been involved with premarket approval of in vitro diagnostics, and devices to treat and manage women’s health and diabetes.