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Who should attend CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA
Executives and Senior Managers, R&D Personnel, Design Engineers, Regulatory Professionals, Project Managers, Risk Management Professionals, Clinical Research Professionals
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CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA  

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Seminar Summary:

FDA has granted precious few applications for waiver since their 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. (see full course description)

 
 

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Training Course Syllabus:


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

FDA has granted precious few applications for waiver since their 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, has discouraged companies from bringing new innovations to this critical public health sector.

With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome?

By attending this this two-day workshop conference on Clinical Laboratory Improvement Amendments (CLIA) attendees will:

Know how to submit a CLIA Waiver application that conforms to FDA’s CLIA Waiver guidance.
Understand how the FDA determines performance requirements for CLIA Waiver and what to expect during their review.
Learn how to design risk-based “flex” studies and develop cost-saving product development and clinical study strategies.
Be able to review FDA’s CLIA categorization criteria and examine ways to incorporate “simple” and “negligible chance of erroneous results” into product design.
Understand how CLIA Waiver requirements have evolved, FDA’s point of view and how to maximize your chances for a successful CLIA Waiver application.

Learning Objectives:

Upon completing this course participants will know how to:
Use FDA’s CLIA categorization scoring criteria.
Understand FDA’s 2008 CLIA Waiver Guidance and cope with its shortfalls.
Integrate human factors and usability engineering into CLIA Waived products.
Design and execute “Flex” studies based on risk analysis.
Design and execute CLIA Waiver clinical studies for qualitative and quantitative devices.
Design and execute studies and sample panels to evaluate performance near the cutoff.
Develop compliant labeling for CLIA Waived products.
Prepare a CLIA Waiver application.
Perform and present statistical analysis of data.
Avoid costly mistakes.
Apply money- and time-saving strategies for development of CLIA-Waived products.
Maximize the chances for a successful CLIA Waiver application.

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

CLIA 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
  • DAY 02(8:30 AM - 1:00 PM)

    “Other” Tests Not Covered By Guidance

  • Study design and submission strategies to save time and money
  • Labeling for CLIA Waived products
  • Preparing and Submitting a CLIA Waiver Application

  • Application framework
  • eCopy requirements
  • Questions and Wrap-Up

    Seminar Summary:

    FDA has granted precious few applications for waiver since their 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. (see full course description)

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