Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process 2015 is an event dedicated to Latest FDA Proposed Changes to the Process.
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process 2015 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
