What this means for you:
This Guidance Document is essential to read and understand if you are involved in this process. Health and Human Services have delegated authority to the FDA to determine whether a test is simple enough to have little chance of producing an erroneous result. The CMS (Centers for Medicare and Medicaid) is responsible for oversight of clinical laboratories. Waivers would apply to procedures or laboratory examinations where the risk of an erroneous result is unlikely where (a) employment of methodologies that are simple and accurate and (b) that the regulatory agency deems pose no unreasonable risk of harm.
Also, all IVD manufacturers note the dual 510(k) and CLIA Waiver by Application pathway will be a real time-saver!
Be sure to read the Guidance Document on CLIA categorization.
The Team at Compliance Insight