The FDA has just released a new guidance document, “Administrative Procedures for CLIA Categorization – Guidance for Industry and Food and Drug Administration Staff.” It describes the classification system for clinical laboratories that accept tissues taken from people for diagnosis or treatment of disease. It is geared for organizations that rely on those laboratories for FDA regulatory compliance, particularly for IVDs (in vitro devices). This FDA Guidance for CLIA Categorization updates information on FDA administrative processes for the CLIA process, including the e-copy program which is voluntary for this situation.
CLIA testing is divided into 3 levels: waived tests, moderately complex tests, and highly complex tests. The FDA catagorizes the tests for a particular device when it is submitted for 501(k) or premarket approval. At this point it is assigned a CLIA Record number (CR). The particular level of complexity assigned by the FDA then means that any testing lab used must be cleared for tests at that level.
This guidance covers the process of assigning the CR number. It also reviews what to do if your product does not need 501(k) or premarket approval, but is still covered by the CLIA requirements. You’ll get a CR number too, and the protocol is included in this guidance. It also has a section on the issue of waiver protocols and applications.
While the FDA guidance documents are not enforceable, they provide industry will a clearer understanding of the processes of FDA regulators. And they can also clarify how the FDA views certain topics or issues that may affect your products. If CLIA affects your business, you may also want to review the “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” from 2008.
The move to using electronic submissions for these types of activities has been prompted by the paperwork reduction act. As the FDA discovers the benefits to staff in using online protocols and the benefits gained from the automatic database generation inherent in these systems, more processes are being moved online.
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