FDA Offers Considerations for Switching Devices From Rx to OTC Status

September 9, 2021

The FDA has responded to frequently asked questions about which types of devices may be offered as over the counter (OTC) devices and what devicemakers should consider when making the switch from prescription to OTC status.

Most OTC medical devices are low-risk Class I devices that don’t require premarket review, but some are moderate-risk Class II devices, and some are even high-risk Class III devices, the agency said.

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, the FDA said.

OTC devices are typically devices that may be used in any setting where the consumer can easily use the device as directed by product labeling, the agency said.

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