Promoting Devices for Specific Indications Based Upon a General Clearance

Many medical devices receive 510(k) clearance from FDA for general indications but are labeled and promoted for more specific indications. Frequently, 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. For example, if an excimer laser device has general clearance for cutting or coagulating soft tissue, then FDA may treat promotion specifically for photorefractive keratectomy as a new intended use. In many cases, manufacturers are surprised by FDA’s position, believing that their labeling and promotional activities were consistent with the original clearance. This article discusses disputes with FDA over the scope of 510(k) clearance and provides advice on how to navigate this difficult area.