CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA: One and a Half Day In-person Seminar

By: Glenn Neuman, Director of Scientific Affairs at New World Regulatory Solutions, Inc.
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Course Description:

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.

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 considering or planning to undertake CLIA Waived product development and people who will be involved in the submission of applications for CLIA Waiver to FDA. The course will be presented to address all levels of interest, from executive to technical and clerical. The following personnel will benefit from attending this course:

  • Executives and Senior Managers
  • R&D Personnel
  • Design Engineers
  • Regulatory Professionals
  • Project Managers
  • Risk Management Professionals
  • Clinical Research Professionals

Course Outline

Day One (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 Two (8:30 AM – 01:00 PM)
    • Labeling requirements
    • Hands-on: Preparing graphs with ATE and LER in Microsoft® Excel®
    • Questions and wrap-up

    Meet Your Instructor

    Glenn-Neuman-90X112
    Glenn Neuman
    Director of Scientific Affairs at New World Regulatory Solutions, Inc.

    Glenn Neuman is a seasoned Regulatory Affairs professional with an R&D background. Mr. Neuman has over 20 years’ experience with CLIA Waivers, and presented at CLIAC meetings and at FDA’s watershed CLIA Waiver public workshop in August of 2000. He has been intimately involved with the CLIA Waiver process throughout its evolution to the present day. He has served as the Director of Scientific Affairs for New World Regulatory Solutions, Inc. (NWRS) since 2004. NWRS is an independent consulting firm that works with start-up to global 500 companies in the areas of device design and human factors, risk management, clinical studies, regulatory submissions to FDA and quality system regulations.

    Prior to joining NWRS in 2004, he was Director of R&D and then Director of Regulatory, Quality and Technical Affairs at Wampole Laboratories during its ownership by Carter Wallace and Inverness Medical Innovations (now Alere), respectively. He holds a Master’s degree in biochemistry from the University of Maine.

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