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Event NameCompliance Global 2017 Fundamentals Of The De Novo Process For Medical Devices
Event Date(s) Wednesday, January 11, 2017  to Wednesday, January 11, 2017
Event Location New Hyde Park
New York, New York
Cost$195 - $495


This webinar will describe the legal and regulatory basis for the de novo program and discuss the de novo device submission process. And provide information as to what constitutes a good quality de novo submission and will identify resources useful in preparing a de novo medical devices application.

Why Should You Attend

The device approval process can be complex and time consuming and may not always result in obtaining FDA approval. Pursuing a Pre-Market approval or PMA approval for a new medical device can be especially costly and require substantial resource commitments. Knowing whether you can submit your device through the de novo process may result in cost savings not only in upfront resource burn but also in faster time-to-market for your medical device.

Areas Covered in this Webinar

  • What is the definition of de novo? A brief history of the medical device regulations with respect to section 513 of the FD&C Act (device classification system) 
  • Description of the de novo process (section 513(a)(1)) and the two pathways used to pursue FDA approval  
  • Links to FDA guidance documents available and other useful references 
  • Best practices and helpful hints to help facilitate the de novo process and submit a good quality application

Learning Objectives

  • Will be able to understand the similarities, interrelationships, and differences between 510(k), PMA and de novo medical device approvals 
  • The appropriate path to take when seeking approval of a new medical device or new indication for use of a prior approved device
  • The different pathways to interact with the FDA when pursuing a de novo application
  • Knowledge of section 513(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act)

Who Will Benefit

  • Medical Device Professionals
  • Regulatory Affairs Managers
  • Corporate Device Managers responsible for submitting medical device applications for new devices or for new indications for use
  • Small Business Owners who will be submitting a device for approval with the FDA
  • Regulatory Consultants

SponsorRebound Therapeutics
Host CompanyRebound Therapeutics
Contact Information Phone: +1-516-900-5515
Fax:   +1-516-900-5510 
More Information