Considerations for device manufacturers OTC medical devices

Aug. 26, 2021

Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these devices do not require a prescription for sale.

Some, but not all, OTC medical devices are Class I (low risk) devices that do not require premarket review. Many are Class II (moderate risk) and some are even Class III (high risk) devices, both of which generally require premarket review. Additionally, not all home use devices are intended for OTC sale; some home use devices require a prescription.

OTC medical devices may be used in any setting where the consumer can properly use the device as directed by the product labeling. For instance, the device may be used outside the home in an office, school, hospital, ambulatory surgical center, nursing home, outpatient treatment facility, or other healthcare facility.

Q: What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?

A: Like OTC drugs, OTC medical devices typically have the following characteristics:

  • They can be used outside of healthcare settings.
  • They are adequately labeled such that:
    • The consumer (lay user) can self-diagnose their condition, self-select that the device is appropriate, self-treat and self-manage the condition that the device is intended to treat or diagnose.
    • The consumer (lay user) is able to understand how to use the device correctly (based on the labeling, including the instructions) without any help from a healthcare provider.
  • The device has low potential for reasonably foreseeable misuse.
  • The safety margin is such that the benefits of having an available OTC device outweigh the risks.

Changing a 510(k)-cleared device labeled for prescription use only to a device labeled for OTC use would likely require a new premarket submission. Such a change typically could significantly affect the safety or effectiveness of the device because the directions for use necessary for health care professionals to use a device safely and effectively can be significantly different from the directions for use necessary for lay users to use that same device safely and effectively.

FDA release