Medical devices are often used to diagnose vision problems or enhance visual function for patients and may be appropriate for patients who live with visual impairment, low vision, severe blindness, or conditions that diminish functional level of vision. The U.S. Food and Drug Administration regulates medical devices and oversees the process of moving devices from premarket phases through distribution, labeling, usage, and reporting of adverse events. Examples of medical devices in vision and eye health include contact lenses and contact lens care products, diagnostic imaging products, implants, intraocular lenses, lasers, and surgical instruments.
Prevent Blindness has consistently advocated for policies that enhance safety, efficacy, and quality of care around medical devices. Recent regulatory action from the Centers for Medicare and Medicaid Services (CMS) has examined the pathways to coverage for devices that are considered to be “breakthrough” or “innovative” devices. The regulatory pathway from market to approval, coverage, and coding can often mean that patients must wait longer to receive coverage for various devices and technologies.
As these policies continue to move forward under debate, Prevent Blindness will review policies to ensure that patients can access safe, effective, and in line with standards of care that reflect values of quality and patient-centeredness.