Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2016

Topics

• The Process
  • When a 510(k) is Not Required
  • Who is Required to Submit a 510(k)
  • Locating and justifying the Predicate
  • When a 510(k) is Required
  • How to Prepare Submissions
  • Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
  • List of forms associated with Premarket Notification 510(k) submissions
  • 510(k) Submission Methods
  • What happens if FDA requires additional information and data and your responsibilities
  • Deciding When to Submit a 510(k) for a Change to an Existing Device
• Introduction and Regulatory Background
  • Current trends with the 510(k) process
  • There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission
• Interactive Q&A, Wrap-Up and Adjourn
  • Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
  • Q&A with all attendees
  • 510(k) Frequently Asked Questions
  • Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc
  • Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session