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FDA Medical Device, Frequently Asked Questions for (OTC) Device Manufacturers

December 23 2022

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 examples of OTC medical devices include bandages, menstrual products, and condoms.

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.

Frequently Asked Questions :

Q: What considerations may be relevant when designing an OTC device?

A: Consumers may have different physical, sensory (vision, hearing, tactile), cognitive, and emotional abilities than health care professionals, such as different literacy levels and ability to process information. These capabilities and others may be relevant considerations in the design of an OTC device.

For example, design considerations for an OTC device would ideally consider ease of use and understanding by the end user, to prevent reasonably foreseeable misuse.

Q: What is the role of human factors testing for OTC devices?

A: As part of the design control process for devices, manufacturers conduct a risk analysis to assess the risks associated with device use and the measures necessary to reduce those risks. If the results of the risk analysis indicate that users performing tasks incorrectly or failing to perform tasks (use errors) could cause or result in serious harm to the patient or the device user, the manufacturer should apply appropriate human factors or usability engineering processes and submit the human factors data in the premarket submission. For details, see Applying Human Factors and Usability Engineering to Medical Devices (final guidance).

Human factors testing can play an especially critical role in identifying the hazards associated with the use of a medical device by lay persons, and usability testing is a particularly effective human factors method. For an OTC usability test, representative lay persons would perform selected tasks under conditions of simulated (not actual) use in an appropriately realistic environment, such as the home setting. Usability testing should occur early in the design process and then periodically as the design evolves to prevent user interaction problems from persisting into the later stages of the design process. For details, see Design Considerations for Devices Intended for Home Use (final guidance).

Q: What are the labeling considerations for OTC devices?

A: The FDA’s regulations in 21 CFR Part 801, subpart C, set forth specific requirements for labeling OTC devices. In general, labeling for OTC medical devices should be simple, visible, concise, and easily understood by the lay person, with narratives or pictures where appropriate. The labeling should also include contraindications that explain why any individual should not use the device and include clear warnings of all hazards. In addition, the labeling should be accessible to users even when the device may become separated from the labeling; for example, labeling could be accessible on a website or through calling the manufacturer.

Q: What is the process for bringing a novel OTC device to market?

A: For novel devices that cannot be reviewed through the 510(k) pathway due to lack of a predicate device, the De Novo classification process may be an option. The De Novo process provides a pathway for classifying novel devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

The De Novo request will include a description of the probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended. For OTC devices, risks might include misinterpretation or over-reliance on device output, which might be addressed through human factors and usability engineering testing under simulated conditions of use and risk mitigation measures, including appropriate information within labeling.

Q: What are the Unique Device Identifier (UDI) requirements for OTC devices?

A: The UDI regulations do not include requirements specific to OTC devices; however, the Global Unique Device Identification Database (GUDID) reporting requirements include an optional identification of whether a device is OTC or prescription. A Class I device that bears a Universal Product Code (UPC) on its label and device package can use the UPC to meet their UDI labeling requirements. While a Class I device with a UPC on the label and package is subject to GUDID reporting, the lowest risk Class I devices available for sale at retail establishments will be GMP exempt and thereby excepted from all UDI requirements.

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