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


Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process covers topics such as:

  • 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

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