Promoting Devices for Specific Indications Based Upon a General Clearance

Many medical devices receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) for general indications but are labeled and promoted for more specific indications. Frequently, the FDA asserts that such specific uses are not covered by the original clearance and require separate 510(k) clearance or even premarket application (PMA) approval. This article discusses disputes with the FDA over the scope of 510(k) clearance and provides advice on how to navigate this difficult area.