Clia waiver clinical trials

The dual submission program is designed to provide simultaneous review of both applications for k premarket notification and CLIA Waiver by application with the purpose of reducing time spent on the authorization processes.

It will be important for manufacturers to capitalize on the dual submission pathway to optimize business efficiencies. As of March , there are a total of , laboratory sites and 79, physician office laboratories that can perform CLIA-waived testing in the United States.

The guidance document published by the FDA in February aids medical device manufacturers in the development of study designs for dual submission and outlines the criteria used to determine whether this framework can be applied.

A key takeaway from this guidance is the suggestion that while k IVD studies are often performed by trained operators, such as test operators or moderate complexity laboratory personnel, it is important to design a dual pathway study to replicate settings, samples and test operators to demonstrate CLIA Waiver criteria. Most importantly, the FDA provides guidance for designing a single set of comparison and reproducibility studies with the data generated supporting both k clearance and CLIA Waiver requirements.

Device manufacturers are encouraged to inform the FDA of its plans to leverage a dual submission pathway with a Pre-Submission notification. FDA further recommends that the Pre-Submission process includes planned study designs for comparison and reproducibility studies developed by the device manufacturer to suit the requirements applicable to both k premarket notification and CLIA Waiver applications.

Typically, a dual submission should include all content required for the application of k clearance and CLIA Waiver by application as though these submissions were separate and sequential.

To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. Send your completed application to the address of the local State Agency for the State in which your laboratory or testing site is located.

Additionally, check with your State Agency for any other state-specific requirements. If you do not have online access and do not have information about your State Agency, you may contact the CLIA program at for the address and phone number of your State Agency.

The recommendations were published to promote quality testing, reduce testing errors, and enhance patient safety. This self-assessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a Clinical Laboratory Improvement Amendments CLIA Certificate of Waiver. It can be used as a voluntary tool to help assure good testing practices and reliable, high quality test results.

To Test or Not to Test? Spanish Version This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver. From diabetes management to screening for infectious diseases, CLIA-waived tests have become an integral part of patient care at or near the patient and can be performed using hand-held devices at the bedside or at the Point-of-Care POC.

To be awarded CLIA waiver status, manufacturers must demonstrate that a specific test system is easy to use, carries low risk associated with an incorrect result and is accurate in the hands of the intended user.

Username or Email Address. Remember Me. Advanced Search Show. Selecting multiple options vary in different operating systems and browsers: For windows: Hold down the control ctrl button to select multiple options For Mac: Hold down the command button to select multiple options. Privacy - Terms. Results per page:.