Draft Waiver Guidance Release

On November 29, 2017 FDA released two new FDA draft guidance documents - one regarding it recommendations regarding determination of accuracy, and the other regarding the dual submission process.  With regard to the accuracy guidance, significant improvements are still required to ensure the CLIA waiver process is improved and access to important waived tests is not hindered by a misunderstanding of requirements. 

It is critical that all interested stakeholders to voice the need to for a more flexible approach to waivers that focuses on the user.  Please see our comments on the "accuracy" guidance and comments on the dual submission guidance for more information.   FDA Please e-mail jboiani@ebglaw.com to join our Coalition Outreach mailing list and get further information.



To bring together interested stakeholders from all quarters to press for a return to the principles and precedents, which will expand access to CLIA-waived point-of-care testing for the benefit of patients.


The Coalition for CLIA Waiver Reform is an organization dedicated to improving access to safe and effective diagnostic testing at the point-of-care by reforming the U.S. Food and Drug Administration's  CLIA Waiver Program.

Point-of-care testing –- running a test where the patient and healthcare provider are located, as opposed to sending out patient specimens for analysis at off-site laboratories –- can save time, lives, and valuable healthcare dollars.  The majority of point-of-care testing in the US today is done at CLIA-waived laboratories, which represent nearly 70% of all laboratories in the United States.  By law, these laboratories must exclusively use tests that are assigned a "waived" (low) complexity rating by the U.S. Food and Drug Administration.


Unfortunately as a result of current regulation, both innovation of waived tests and access to novel diagnostic tests has been severely hindered.  Furthermore, tests which are easier to use and would improve quality of CLIA-waived testing are denied entry to the CLIA-waived testing environment.

Many events, and organizations with in interest in both medical innovation and public health.  Also, there is a growing appreciation that the problem holding back access to new and better point of care testing is the FDA regulatory process, and specifically FDA's current policies with regard to  of CLIA waiver accuracy requirements, which were published in 2008, which are inconsistent with law.  For that reason, Congress included a provision in the 21st Century Cures Act requiring FDA to revisit it policies and publish new guidance.


The Coalition for CLIA Waiver Reform is an organization dedicated to changing the regulatory process for obtaining CLIA Waivers so the full benefit of safe and effective CLIA-waived tests can be brought to patients.  We welcome everyone –- patients, doctors, associations, CLIA-waived labs, legislators, diagnostics companies, and other members of the public –- to join us in the quest for better better regulation in the interest of public health.  To find out more about what you can do please contact us and read our newsletter.

Improving Access to Point of Care Testing through Sound Science & Regulatory Reform