FREQUENTLY Asked Questions

What is the difference between a 510(k) and a CLIA Waiver?

View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

While a premarket notification (510(k)) and CLIA Waiver by Application each include discrete elements not required in the other, both submissions generally include comparison and reproducibility studies. For a 510(k), such studies are often performed by trained operators (i.e., test operators who meet the qualifications to perform moderate complexity testing, sometimes referred to as “moderate complexity users”). For a CLIA Waiver by Application, such studies should be conducted by the intended user (i.e., test operators in waived settings and with limited or no training or hands-on experience in conducting laboratory testing, sometimes referred to as “untrained operators” or “waived users”).

Related Terms:
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST