Guidance on CLIA categories affects testing devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, May 26, 2008
The FDA has issued guidance on the FDA’s procedures for categorizing the complexity of in vitro diagnostic (IVD) tests. Manufacturers submitting pre-market notifications for tests should be aware of the guidance. The guidance does not address CLIA waiver applications, which is the subject of separate guidance.
The FDA categorizes IVD tests when it reviews 510k submissions or pre-market approval applications for the tests. If such a filing isn’t appropriate for a test, the manufacturer should request a CLIA categorization by submitting a copy of the test package insert and test instructions to the FDA.
The FDA uses the information in the test instructions provided in the pre-market submissions to make its categorization decision. The guidance includes a table describing the information or documentation that should be submitted to speed the categorization process—depending on the type of submission being filed. All types of filings require a package insert with additional information required for certain filings. If any changes are made to the name of the device or the manufacturer changes, the FDA should be notified.
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