The U.S. Food and Drug Administration (FDA) has published practical guidance for manufacturers of over-the-counter (OTC) medical devices, explaining that marketing a device directly to consumers does not exempt it from regulatory requirements or from demonstrating that an ordinary user can operate it safely and effectively. This category includes products such as bandages, menstrual products, condoms, some blood glucose meters, and some hearing aids.
Making a device available for home use does not automatically make it OTC; some home-use devices still require a prescription. Likewise, OTC devices may be used outside the home, such as in an office, school, hospital, or nursing home, as long as the consumer can use them according to the labeling instructions.
When Is a Device a Candidate for OTC Use?
According to the FDA, a device considered for this category should enable an ordinary user to self-diagnose their condition, select the appropriate device, and treat or manage the condition without assistance from a health care provider and based on the labeling and instructions for use. The risk of reasonably foreseeable misuse should also be low, and the benefits of making the device directly available to consumers should outweigh its risks.
Examples cited by the agency include some continuous glucose monitoring devices and some hearing aids regulated under 21 CFR 874.3300, 21 CFR 874.3302, 21 CFR 874.3305, 21 CFR 874.3315, 21 CFR 874.3325, and 21 CFR 874.3950, as well as OTC electrosurgical devices for cosmetic use, influenza tests, home pregnancy tests, and fertility-tracking devices.
Converting from Prescription to OTC
Converting a device authorized under a 510(k) for prescription-only use into a device available OTC generally requires submitting a new application before marketing. The reason is that the instructions needed by professionals may differ substantially from those needed by ordinary users, which may affect the device’s safety or effectiveness.
The 510(k) pathway may remain appropriate if ordinary users fall within the intended use of the predicate device and the data demonstrate their ability to use the device safely and effectively. However, if the changes raise a different question of safety or effectiveness, a De Novo classification request or a premarket approval (PMA) application may be required. Real-world evidence (RWE) may also be used to support regulatory decisions, including expanding a device’s labeling or supporting conversion from prescription to OTC, provided that the real-world data are of sufficient quality for the specific decision.
What Changes in Practice in Design and Testing?
The FDA emphasizes that ordinary users may differ from professionals in visual, auditory, tactile, cognitive, and emotional abilities, as well as in reading levels and information-processing abilities. Human-factors and usability-engineering considerations should therefore be incorporated during the early design and development stages and repeated as the product evolves.
Testing generally includes ordinary users representing the target populations who perform selected tasks under simulated-use conditions and in an appropriate realistic environment. The agency recommends including participants from the United States because differences in units of measurement or language may change how labeling and training are understood. Conditions such as low lighting, multiple alarms, distractions, and performing multiple tasks simultaneously should also be simulated. If the risk assessment shows that use errors could create an unacceptable risk to the patient or user, the company should implement appropriate controls to reduce that risk.
Labeling, Cleaning, and Market Launch
OTC device labeling is subject to the requirements of 21 CFR Part 801, subpart C, and should be simple, clear, concise, and easy for an ordinary user to understand, using explanatory text or images when necessary. It must also include clear contraindications and warnings about risks, and the information should remain available even if the device becomes separated from the packaging, such as by providing it on a website or through contact with the company.
Devices requiring cleaning or disinfection should be designed so that a nonprofessional user can clean them with readily available materials and simple methods, with those methods explained in the labeling. The De Novo pathway provides an option for new devices that lack a valid predicate device for the 510(k) pathway, based on a risk-benefit assessment; risks may include misinterpretation of the device’s outputs or overreliance on them.
Software, Studies, and Regulatory Data
Digital health software functions are regulated as devices if they meet the definition of a device under the FD&C Act. Under section 520(o)(1)(B), software intended to maintain or encourage a healthy lifestyle is excluded if it is not related to the diagnosis of, cure of, mitigation of, prevention of, or treatment of a disease or condition. Software and connected devices raise additional considerations, including software validation, cybersecurity, and interoperability.
There are no special UDI requirements for OTC devices, but the GUDID rule allows optional reporting of whether a device is OTC or prescription. In addition, some Class I devices bearing a UPC on the label and packaging may use it to meet UDI requirements, with an exception for the lowest-risk Class I devices available for retail sale if they are exempt from good manufacturing practices.
Before submitting a 510(k) or De Novo request, a manufacturer may use the Pre-Submission process to obtain FDA feedback on the need for a clinical study or its objectives, participant inclusion criteria, and follow-up duration. Clinical studies remain subject to participant-protection requirements, including informed consent under 21 CFR Part 50, institutional review board requirements under 21 CFR Part 56, IDE requirements under 21 CFR Part 812, and financial disclosure requirements under 21 CFR Part 54. Thus, the FDA framework makes clear that the success of an OTC device depends as much on the product’s suitability for the ordinary user as on its regulatory pathway.