Course "FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

Each year the FDA receives approximately four thousand 510(k) Notifications per year. In the last few years the FDA has made significant changes to the 510(k) Notification process should as the institution of the FDA’s Refuse to Accept Criteria for a 510(k) Notification submission and limiting the number of predicate devices that can be used to show substantial equivalence. Obtaining market clearance in a timely manner allows a company to bring new or improved products to market sooner.

This 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. In addition, comparison tables to show substantial equivalence will be reviewed.

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.

Learning Objectives

Upon completing this course participants will understand:

  • Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
  • When to file for a new device, a change in the intended use or a change in the technology of a cleared device
  • What is contained in a traditional, abbreviated and special 510(k) submission package
  • The submission package, user fees and making an eCopy
  • What is substantial equivalence and what’s required to show substantial equivalence
  • What’s required on the labeling and IFU
  • Which performance tests should be conducted and how to present the data to the FDA
  • The requirements for a risk management plan and report
  • Understand the FDA’s Refuse to Accept Policy
  • What is required in a submission for software controlled devices
  • How and when to use third party reviews
  • When clinical data may be required

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who Will Benefit:

This course is designed for individuals who are tasked with preparing a 510(k) Notification or part of a team preparing a 510(k) Notification. The following personnel will benefit from the course:

  • Company CEOs and Presidents
  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Regulatory and Quality Assurance Professionals
  • Design Engineers
  • Quality Engineers
  • Legal Professionals

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (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
  • 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

Meet Your Instructor

James Barley
Regulatory Affairs and Quality Assurance Consultant

James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These services included setting up quality systems compliant with the FDA’s Quality System Regulation, ISO 9001 and ISO 13485.

In addition, Mr. Barley has prepared 510(k) submissions for instruments, disposables, electronic equipment and software as well as Technical Files for Class Im, 1s, IIa and IIb. Since the FDA has begun enforcing its Refuse To Accept Policy, Mr. Barley has successfully navigated through the requirements of the FDA Policy.

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