FDAnews Announces — New Management Report — Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

Share Article

To get a new medical device to market faster, devicemakers can use one of three options to bypass the lengthy clinical trial and literature search processes and get rapid FDA feedback. But which should be used: the De Novo program, Early Feasibility/First-in-Human Studies or the Expedited Access Pathway?

FDAnews

FDAnews

To get a new medical device to market faster, devicemakers can use one of three options to bypass the lengthy clinical trial and literature search processes and get rapid FDA feedback. But which should be used: the De Novo program, Early Feasibility/First-in-Human Studies or the Expedited Access Pathway?

This report explains the criteria for each pathway, how to determine which one is right for a device and strategies for success. Fictional cases illustrate how the different pathways can be used. Readers will learn:

  •     The benefits and requirements of the de novo, early feasibility/first-in-human and expedited access pathways
  •     How to determine which pathway is the most efficient
  •     How the passage of the 21st Century Cures Act and the impending MDUFA goals are potential game-changers in pathway determination
  •     How to optimize effective communications with the FDA, depending on which pathway is best suited for a product

Efficient Premarket Applications will help save time and money in the submission process.

Who Will Benefit:

  •     Regulatory Affairs
  •     Quality Assurance
  •     Clinical and Medical Affairs

FDAnews Management Report Details:
Efficient Premarket Applications:
Three FDA Submission Paths That Require Less Time, Money and Effort
Price: $397
http://www.fdanews.com/products/54770-efficient-premarket-applications    

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54770-efficient-premarket-applications        
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.

Efficient Premarket Applications:
Three FDA Submission Paths That Require Less Time, Money and Effort
**An FDAnews Management Report**
http://www.fdanews.com/products/54770-efficient-premarket-applications

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