510(k) Submission Preparation:

How to Build a Submission Package & Get FDA Clearance to Market

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
 
Medical device 510(k) experts will teach and provide an understanding of how to get a device requiring a 510(k) submission to market quickly with minimal or no delay. You have heard the horror stories, now you can find out how to prevent them from happenning to you. 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 and has not become any easier. Getting the 510(k) submission through the FDA review process as quickly as possible is financially and competitively critical to most companies. The instructors will describe the submission process and the submission package required by the FDA for successful submissions. Learn from their experience having sucessfully submitted numerous 510(k) submissions for a wide variety of medical devices. You will learn about trends and new policies, including FDA's Refuse to Accept (RTF) and E-copy Policies. Approximately 30% of submissions are refused on the first submission! The instructors will discuss a real life 510(k) submission example and will provide an understanding of the common pitfalls, delays, and possible preventative measures. Also they will discuss the type of activities a company can pursue while waiting for submission clearance and what type of risks taken in doing so. We will be discussing submissions and techniques that apply to a wide variety of devices including disposable, reusable, sterile, non-sterile, IVD, and electrical, including software controlled devices.

What you will learn:

• What is Substantial Equivalance (SE)
• 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 to create and assemble a 510(k) submission package
  
• Refuse to Accept (RTF) and E-copy Policy
• What to do if you make a change to your device
• What is required in a submission for Software controlled devices
  
• How to interact with the FDA and the reviewer during a submission review
  
• 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
  
• How to avoid delays
  

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
  

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 & outlines: details
  
• F. How to assemble & submit
  
• G. Use of standards and guidance documents
  
• H. What are 3rd Party reviewers & when to use
  
• I. How to interact with the FDA Reviewer during the submission review
• J. E-Copy & Refuse to Accept (RTA) Policies (~30% are still refused when first submitted)
  
• K. Clinical Data Requirements
  
• L. How to handle Requests for Additional Information and NSE letters
• M. How to handle device changes and your 510(k), including the new final guidance.
  
• N. Review & Summary

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.



Request a training proposal for your company.