New AOA resource on FDA regulatory and advertising requirements

The AOA has released a new resource to help its members understand—and comply with—U.S. Food and Drug Administration (FDA) regulatory and advertising requirements. Titled “Understanding FDA Approval and Clearance and the Impact on Optometry Advertising,” the resource parses the distinction between off-label use and off-label marketing to help AOA members remain compliant. The document also explains the FDA’s regulatory requirements for device manufacturers to help doctors of optometry evaluate medical devices.

Off-label use vs. off-label marketing

Off-label use of FDA-approved drugs and medical devices—that is, using them differently than what the FDA approved them for—is common for doctors of optometry and other physicians. An example is prescribing a steroid eye drop for symptoms of dry eyes when FDA approval for the steroid is only post-operative inflammation.

However, it is illegal to advertise or market those off-label treatments. An example is promoting on social media the use of a medical device to treat “dry eyes” if the device does not have that approval.

That’s why it’s crucial for doctors of optometry to ask vendors for specific FDA approval/clearance language, so they know the exact guidelines of advertising, says Jeffrey Michaels, O.D.

“When ODs ask vendors for advertising advice, the vendor often sends an example of what another doctor is advertising,” he says, “but the advertising is not always in compliance. Use the FDA approval/clearance language as your guide.”

Understanding FDA approval and clearance

All medical device companies must register with the FDA to sell their device in the United States. Medical devices are classified by the FDA as follows:

• Class I (low to moderate risk)
• Class II (moderate to high risk)
• Class III (high risk)

How a device is classified impacts whether the device must be “FDA approved” or “FDA cleared.” An example of an FDA-cleared device is eyeglass lens technology to slow myopia, while devices to treat signs and symptoms of dry eyes are usually in the FDA-approved category.

When purchasing new equipment for an optometric practice, doctors of optometry should inquire with company representatives about their product’s status with the FDA.