Clinical Laboratory Improvement Amendments (CLIA) Waivers

CLIA Waivers

About CLIA Waivers

A CLIA-waived complexity allows your device to be used in over 170,000 Certificate of Waiver laboratories in the US.

These waived sites are typical doctors’ offices, or clinics where rapid point-of-care testing is desirable.

To be eligible for waiver, tests must meet special design and performance guidelines, and be evaluated under separate regulatory requirements.

If you are interested in having a test system that qualifies for CLIA waiver, NWRS can help.

NWRS and CLIA Waivers

NWRS has successfully shepherded CLIA Waiver applications through the continuously evolving regulatory process since 1993.

NWRS experience with the FDA and the CLIA waiver process has resulted in a proven record of success in obtaining CLIA waivers for our clients.

New World Regulatory Solutions will:

  • Interact with the FDA
  • Recommend device design that meets CLIA waiver requirements
  • Create specialized labeling that meets CLIA requirements
  • Develop protocols for CLIA waiver studies
  • Negotiate FDA agreement on study design and protocols
  • Conduct all CLIA waiver studies (Field and Laboratory)
  • Analyze data
  • Prepare and submit CLIA waiver application to the FDA
  • Track the FDA review of your submission
  • Address and solve FDA concerns

Contact NWRS About CLIA Waivers

CLia Links and Forms

Are you seeking a Certificate of Waiver for your laboratory? CLIA certification forms are available on the CMS website.

CLIA Certification Forms

Additional links to CLIA information below:

CLIA Home Page Searchable Database of CLIA-Waived Tests List of Tests Waived by FDA Since 2000