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Seminar Summary:

This 2 day course will show how to submit a traditional, abbreviated and special 510(k) for a Class II Medical Device. It will discuss what to look for in a predicate device and how to show substantial equivalence. (see full course description)

 
 
 

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Training Course Syllabus:


FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

Course Description:

Each year the FDA receives approximately four thousand 510(k) Notifications per year. Starting in January, 2014, the FDA began enforcing the FDA’s Refuse to Accept Criteria for a 510(k) Notification submission. Obtaining market clearance in a timely manner allows a company to bring new or improved products to market sooner. One of the key steps in submitting a 510(k) Notification is selecting the predicate device and being able to show substantial equivalence between your device and the predicate device.

This 2 day course will show how to submit a traditional, abbreviated and special 510(k) for a Class II Medical Device. It will discuss what to look for in a predicate device and how to show substantial equivalence. This includes visual, dimensional and functional comparisons.

Upon receipt of a 510(k), the FDA reviews the 510(k) within 15 days as part of the Refuse to Accept Policy to verify that all of the required elements are included in the 510(k) submission. This course will review the FDA’s Acceptance Checklist for 510(k) s that the FDA uses for the Refuse to Accept Review and also provide helpful hints for passing the FDA’s initial review.


Course Outline:

Day One (8:30 AM – 4:30 PM)


Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

The 510(k) regulation
Types of 510(k) submissions
Traditional
Abbreviated
Special
Preparation of a Traditional 510(k)
Substantial equivalence
Labeling requirements
Performance testing
Substantial equivalence testing
Risk management documentation
When are clinical trials required
The submission process
User Fees
Payment
Medical Device User Fee Cover Sheet
Submission package
eCopy


Day Two (8:30 AM – 4:30 PM)


Special 510(k)
Why submit a special 510(k) versus a traditional or abbreviated 510(k)
Preparation of a special 510(k)
Detailing the medical device modification
Comparing the cleared device to the modified device
Performance testing
Comparison testing
Labeling requirements
Risk management documentation
Submission package
Abbreviated 510(k)
Preparation of an abbreviated 510(k)
Guidance documents, special controls and FDA recognized standards
The submission process
Submission package
Substantial equivalence
Performance testing summary
Submission package
FDA’s refuse to accept policy
Acceptance checklist for traditional 510(k)’s
 

Seminar Summary:

This 2 day course will show how to submit a traditional, abbreviated and special 510(k) for a Class II Medical Device. It will discuss what to look for in a predicate device and how to show substantial equivalence. (see full course description)

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