Market Overview

One and a Half Day Workshop: CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA (Chicago, United States - August 16th-17th, 2018) -


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

conference has been added to's

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)
  • 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 Should Attend:

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

For more information about this conference visit

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