In August 2014, the FDA issued a draft guidance regarding the De Novo Classification Process.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- Changes to the De Novo Classification Process draft guidance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
Director Regulatory Affairs