Course "How to get a CLIA Waiver for your Medical Device" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

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.

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

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) Day Two (8:30 AM – 1:00 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • 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

  • “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

Meet Your Instructor

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.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

We need below information to serve you better

Best Sellers
You Recently Viewed