FDAnews Announces — Medical Device Premarket Regulatory Pathways: Maximizing Efficiency—Saving Time, Money & Resources Webinar, June 7, 2017

Share Article

There’s a new pathway to medical device sales: the premarket approval process. But as with everything new, there’s a learning curve, so FDAnews has called on two leading NSF Health Sciences consultants to guide devicemakers through the twists and the turns.

Medical Device Premarket Regulatory Pathways:
Maximizing Efficiency—Saving Time, Money & Resources
**An FDAnews Webinar**
June 7, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdpremarketreg                        

A trail being blazed by provisions of the 21st Century Cures Act and proposed Medical Device User Fee Amendments (MDUFA) IV goals not to mention a business-friendly White House promise to decrease premarket-approval costs and speed new products to commercialization.

All devicemakers have to do is figure it all out.

FDAnews is here to help. Mark the calendar for Wednesday, June 7, and the Medical Device Premarket Regulatory Pathways webinar when two NSF Health Sciences senior consultants guide manufacturers down this new path to speedier premarket approvals. Attendees will discover:

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

The 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.

Greater profits, lower costs and speedier premarket approvals await the devicemaker who figures out these new advantages early on.

Who Will Benefit:

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

Webinar Details:
Medical Device Premarket Regulatory Pathways:
Maximizing Efficiency—Saving Time, Money & Resources
**An FDAnews Webinar**
June 7, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdpremarketreg                        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mdpremarketreg                                                                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website