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CDRH Intends to Initiate the Reclassification Process for Most High Risk In Vitro Diagnostic Tests

Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced that the Center intends to initiate the reclassification process for most in vitro diagnostic (IVD) tests that are currently class III (high risk) into class II (moderate risk). The majority of these tests are infectious disease and companion diagnostic IVDs.

Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review.

Reclassification may support the potential for more manufacturers to develop these tests, which could increase competition and provide patients with increased access to these tests.

Questions?

If you have questions about this announcement, contact the Division of Industry and Consumer Education (DICE).