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FDA drafts guidance for diagnostic devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 3, 2007

Device manufacturers who develop In Vitro Diagnostic Multivariate Index Assays (IVDMIA) have some new draft guidance on the definition, status of and pre- and post-market requirements for these devices.

The FDA issued draft guidance in July aimed at helping the device industry and clinical laboratories that develop testing devices and FDA staff that evaluate them. The FDA expressed a need to regulate these devices in part because of safety and effectiveness issues with the devices and healthcare providers' inability to assess the test' validity.

The guidance defines an IVDMIA as a device that "combines the values of multiple variable using an interpretation function to yield a single, patient-specific result" to diagnose a condition or help treat or prevent the condition. Additionally, the result can't be "independently derived or verified by the end user." The guidance provides several examples of what does and does not qualify as an IVDMIA.

The draft guidance addresses pre- and post-market requirements for such devices including when the FDA requires pre-market notification submissions (510K) and applications for pre-market approval. The FDA said pre-market submissions should include data from studies concerning the IVDMIA's use for its intended population and its intended use. Under post-market requirements, the guidance notes the applicability of quality system regulation and says manufacturers must also comply with the medical device reporting regulation. Laboratories developing IVDMIAs are advised to follow the Medicaid reporting requirements applicable to manufacturers.

Click here to review the draft guidance.

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