Overview:
This course will provide an understanding of how to get a device requiring a 510(k) submission to market quickly with minimal or no delay. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to the regulatory and financial health of a company. Getting the 510(k) submission through the FDA review process as quickly as possible is also financially and competitively critical to most companies. This course will describe the submission process and the submission package required by the FDA for successful submissions. The course will provide and discuss a real life 510(k) submission example . It will also provide an understanding of the common pitfalls, delays, and possible preventative measures. Also described will be the type of activities a company can pursue while waiting for submission clearance and what type of risks do they incur in doing so. As a bonus, an overview of how a 510(k) submission can be mapped to a CE Mark technical file will be discussed, thus speeding the marketing of the product internationally.
What you will learn:
- When to submit a 510(k) for a new product or modified product
- Strategies for filing
- User fees and 510(k) submissions
- What is the submission process
- What is contained in a 510(k) submission package
- How is the submission package assembled
- What to do if you make a change to your device
- How device software impacts the submission
- How to interact with the FDA and the reviewer
- How and when to use 3rd Party reviews
- Know when clinical data may be required
- Types of 510(k) submissions and when to use each
- FDA's Least Burdensome Provisions and how they can help you
- How to avoid delays
- 510(k) to CE Mark Technical File Mapping Overview
Benefits of Attending:
- Increased likelihood of a successful submission the first time around
- Probability of product introduction delays minimized due to submission issues
- Higher quality submission package
- Understanding of various submission strategies available
- Know how much detail to include in the submission
- Knowing what to look for when assessing submission risks
- More positive FDA interaction
- Understand Current & Future Global Harmonization Activities
- Jump-start your CE Mark Process
Abbreviated Outline:
- A. 510(k) Regulation & Review Process
- B. Types of 510(k) Submissions & User fees
- C. Submission Strategies and Least Burdensome Principles
- D. Exempt, SE or NSE and why
- E. 510(k) Format and submission example & outlines
- F. How to assemble & submit
- G. Use of standards and guidance documents
- H. What are 3rd Party reviewers & when to use
- I. Interacting with the FDA Reviewer
- J. Clinical Data Requirements
- K. How to handle Requests for Additional Data and NSE letters
- L. Handling Device Changes and your 510(k)
- M. Mapping a 510(k) to CE Mark Technical File, Overview
- N. Review & Summary
Speakers: TBD
