Clinical trials for IOP-lowering devices to support an FDA premarket submission

Abstract

In the United States, the Food and Drug Administration (FDA) regulates the commercialization of devices intended to reduce intraocular pressure (IOP). Depending on the nature of the technology, the indications for use, and the claims being made by the company marketing the device, devices used to lower IOP may be class I (exempt from a 510(k) submission), class II requiring FDA clearance, or class III requiring FDA approval via a premarket application. The FDA evaluates medical devices using information provided by the sponsor of the submission. Among the types of evidence that may be required, clinical investigations involving human subjects may be required to provide reasonable assurance that a device is safe and effective for its intended use. Clinical data provided in support of any FDA marketing application should fit the definition of valid scientific evidence; thus, an appropriate trial design is essential to be able to legally market a device for IOP reduction in the United States.