CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA


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CLIA Waiver applications declined significantly after FDA’s CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, discouraged companies from bringing new innovations to this critical public health sector.

As a result of MDUFA III, passed by Congress in 2012, FDA began accepting and reviewing Dual 510(k) and CLIA Waiver by Applications, and more companies are taking advantage of this new Dual Pathway, which promises shorter review time and higher success rates. Additionally, the 21st Century Cures Act Directs FDA to revise the section on Accuracy in the CLIA Waiver Guidance by the end of 2017. How will these changes impact CLIA Waiver Application outcomes?

You will leave this one and one-half day workshop knowing how to submit either a CLIA Waiver Application or a Dual 510(k) Waiver Application that conforms to FDA’s CLIA Waiver guidance. You will learn how to design risk-based “flex” studies, and develop cost-saving product development and clinical study strategies. We will review FDA’s CLIA categorization criteria and examine ways to incorporate “simple” and “negligible chance of erroneous results” into product design. You will understand how CLIA Waiver requirements have evolved, how the FDA determines performance requirements for CLIA Waiver, what to expect during their review and how to maximize your chances for a successful CLIA Waiver application. Finally, you will gain insights on what to expect from the anticipated new, revised CLIA Waiver guidance.

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

Learning Objectives:

Upon completing this course participants should be confident in their ability to:

  • Understand and follow FDA’s 2008 CLIA Waiver Guidance
  • Prepare an effective Pre-Submission for a CLIA Waiver of Dual 510(k) Waiver
  • Use the CLIA test complexity scoring criteria
  • Integrate human factors into device design
  • Design and execute “Flex” studies based on risk analysis
  • Design and execute CLIA Waiver or Dual Path clinical studies
  • Design and execute studies to evaluate performance at clinical decision points
  • Perform and present statistical analysis of data, including ATE and LER
  • Develop compliant labeling for CLIA Waived products
  • Prepare a CLIA Waiver or a Dual 510(k) Waiver Application
  • Avoid costly mistakes
  • Maximize the chances for a successful CLIA Waiver application

Who will Benefit:

This course is designed for people who are planning to undertake CLIA Waived product development, and people who will be involved in the supporting studies and submission of applications for CLIA Waiver to FDA. The course will address all levels of interest, from executive to technical and clerical. Personnel who will benefit from attending this course include:

  • Executives and Senior managers
  • R&D
  • Design engineers
  • Regulatory professionals
  • Project managers
  • Risk management professionals
  • Clinical research professionals
DAY 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • History of CLIA Waiver Regulations
  • Using CLIA Complexity Categorization Score Card
  • FDA’s 2008 CLIA Waiver Guidance
  • 2 Tiers of Insignificant Risk of Erroneous Results
    • Integrating human factors into device design
    • Designing risk and flex studies
    • Fail-safe and error alert
  • Designing Accuracy Studies
    • Quantitative tests
      • Selecting comparator method
      • Site and operator selection
      • Finding ATE and LER Zones
    • Qualitative tests
      • Selecting comparator method
      • Site and operator selection
      • Near Cutoff Studies
  • FDA’s Dual 510(k) Waiver by Application
  • Importance of the Pre-Submission Program
  • Case Studies
DAY 02(9:00 AM - 1:00 PM)
  • Labeling requirements
  • Hands-on: Preparing graphs with ATE and LER in Microsoft® Excel®
  • Questions and wrap-up
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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