Strategies for Utilizing the De Novo Submission Pathway
1 Hour Video | Bill Brodbeck, Steris Corporation
In August 2014, the FDA issued a draft guidance regarding the De Novo Classification Process. The guidance is intended to address the modifications to Section 513(f)(2) of the Food Drug and Cosmetics Act by section 607 of Food and Drug Administration Safety and Innovation Act . The modifications represent an effort to streamline product approval of low-moderate risk devices. Most notable changes of the new guidance include the elimination of a 510(k) requirement which considerably delayed the De Novo application process. Understanding the criteria, process and content for a successful De Novo application as well as the proper preparation and execution of pre-submission meetings is essential to regulatory affairs executives looking to incorporate this submission pathway into a medical device company’s regulatory strategies.
- Changes to the De Novo Classification Process draft guidance
- Understanding key elements supporting a De Novo application
- Appropriately requesting, planning and executing successful pre-submission meetings
- Reviewing a company’s recent experience with the De Novo submission pathway
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Intelligence
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.
Bill Brodbeck is Director, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. Bill shares the responsibility for FDA submissions and interactions while helping to maintain compliance with FDA requirements, guidance and processes. He is the Regulatory lead for sterility assurance products (SAPs) including biological indicators and chemical indicators as well as Vaporized Hydrogen Peroxide (VHP) Low Temperature Sterilization Systems. Bill received his Ph.D. in the Cellular and Molecular Basis of Disease from Case Western Reserve University and his B.S. in Biology from Wilkes University. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) sterilizations standards committee.