These tests use complex mathematical formulas to interpret large amounts of gene and protein data to produce results that can help guide medical decision-making.

These tests, which FDA refers to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), represent some of the most promising developments in diagnostic testing to date.  The new guidance from FDA will help clarify the agency's regulatory approach to IVDMIAs to assure the public that these tests are safe and effective.

"More and more of these kinds of medical tests are being made available each year," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.  "It is important for the companies and labs making the tests to clearly understand the regulatory requirements in place so that the tests they develop are as safe and effective as possible." 

The draft guidance addresses the definition of IVDMIAs and the regulatory rules for companies and laboratories that manufacture IVDMIAs, including the following.

IVDMIAs employ an algorithm, a specified procedure to solve a problem, to evaluate patient test results along with other clinical information for use in the diagnosis of a disease or condition, or in the cure, mitigation, treatment or prevention of disease.  These tests often include protein and genetic data from patients.  Examples of IVDMIA tests include those used to diagnose and guide treatment decisions for breast cancer, prostate cancer recurrence, cardiovascular disease, Alzheimer's disease and many other complex common diseases. FDA classifies an IVDMIA based on its intended use and on the level of control necessary to assure the safety and effectiveness of the device.  Most IVDMIAs fall under moderate-risk (class II) or high-risk (class III) categories.

A notice has been submitted to the Federal Register (www.fda/OHRMS/DOCKETS/98fr/ch0641.pdf). The agency is accepting public comment for 90 days from the date of publication in the Federal Register.  Comments may be sent to www.fda/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.  Comments must include the docket number (2006D-0347).

The regulation of all medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II) or high-risk (class III) categories.  For some class I, most class II, and all class III devices, FDA review is required before a new medical device can enter the marketplace.  The FDA regulatory program is comprehensive and includes requirements for registration and listing of products, high-quality production using good manufacturing practices and reporting of adverse events once the products reach the marketplace.

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