Over-the-Counter (OTC) Medical Devices

New resource for manufacturers of OTC medical devices to address common questions about the FDA's regulation of these devices.

If your email program has trouble displaying this email, view as a webpage. Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. To assist device manufacturers who are interested in seeking approval or clearance of OTC devices, the U.S. Food and Drug Administration (FDA) developed a new web page to address common questions about the FDA's regulation of these devices. This new page addresses topics such as: Designing OTC devices Conducting human factors testing Fulfilling labeling requirements for OTC devices Addressing clearance and approval considerations for transitioning from a prescription-use-only device to an OTC device Bringing novel OTC devices to market Conducting clinical trials of OTC devices Addressing considerations for OTC software or connected devices Learn More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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