Low to Moderate-Risk Devices – Clarification of the 510(k) Clearance and Dissecting the De Novo Classification

July 21, 2016 10:30am

Jeffrey Senger
Sidley Austin

Jeffrey Gibbs
Hyman, Phelps & McNamara, PC

This session is a ready-to-use strategic primer covering the 510(k) clearance and de novo pathways. The presentation will begin by highlighting the key components of the clearance process and providing practical information for getting to market. Next will be a discussion of 510(k) at the FDA, including current and forthcoming changes to the process. After that will be a discussion of the de novo pathway and when it is appropriate. Finally, the session will provide practical guidance to building a positive working relationship with FDA which, other than your product, is the key foundation to meaningful success with the Agency.

  • Overview of the clearance process
    • Regulatory requirements 21 CFR part 807
    • Premarket notification procedures
      • Importance of strategy and predicate devices
      • Pre-submission process
      • Drafting a 510(k) application
    • What is the review process?
      • Through FDA’s eyes
      • Substantial equivalence determinations
      • Information about safety and effectiveness
      • Not Substantially Equivalent determinations and recourse
  • Regulatory Changes to the 510(k) Process- What to Expect Going Forward
    • Changes and modifications to legally-marketed class I and class II devices- When to file a new 510(k)
    • What to do after modification of a previously-exempt device?
  • Dissecting De Novo Classification
    • When is the de novo pathway appropriate?
    • Presubmission Process- when to use it
    • Classification of the device and effect on next comers
  • Working Successfully with FDA
    • Best practices
    • Building and maintaining a positive working relationship with FDA
    • Institutional reputation
    • Deciding how and when to appeal