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

Thu Oct 19
San Francisco
08:30 AM
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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:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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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
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

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.

Please contact the event manager Marilyn below for the following: - Discounts for registering 5 or more participants.- If you company requires a price quotation.Event Manager Contact: marilyn.b.turner(at)nyeventslist.comYou can also contact us if you require a visa invitation letter, after ticket purchase. We can also provide a certificate of completion for this event if required.NO REFUNDS ALLOWED ON REGISTRATIONS -----------------------------------------------------------------This Event Listing is Promoted byNew York Media Technologies LLC in associationwith Metricstream Inc.http://www.NyEventsList.comhttp://www.BostonEventsList.com


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