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Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers

Over-the-counter (OTC) medical devices are offered for sale directly to the consumer without the need for a prescription. Some examples of OTC medical devices include bandages, menstrual products, condoms, certain blood glucose monitors and certain hearing aids.

Some, but not all, OTC medical devices are class I (low risk) devices that do not require premarket review. Others are class II (moderate risk) and some are class III (high risk) devices, both of which generally require premarket review. Not all home use devices are intended for OTC sale; some home use devices require a prescription. For further information on home use medical devices, see the Frequently Asked Questions About Home Use Devices page.

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 health care facility.

This page provides answers to frequently asked questions about OTC medical devices, including considerations for manufacturers of OTC devices.

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

A: 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.

Examples include:

Q: Does a switch from Rx to OTC for a 510(k)-cleared device require a new premarket submission?

A: Changing a 510(k)-cleared device labeled for prescription use only to a device labeled for OTC use would be a change that likely requires 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.

For more information, see:  

Q: Under what circumstances would a switch from Rx to OTC require a De Novo classification request or premarket approval application (PMA), in lieu of a 510(k) submission?

A: A switch from prescription to OTC use may be reviewed through the 510(k) process as long as the newly indicated population (lay persons) falls within the intended use of the predicate device. Data demonstrating that the lay user can use the device safely and effectively might establish that the indication for use for the new device falls within the intended use of the predicate device. However, if the data show that the changes raise a different question of safety or effectiveness, a De Novo request or PMA may be required.

For more information, see:  

Q: Can real-world evidence (RWE) be used to support a premarket submission for an OTC device, including a switch from Rx to OTC use?

A: The FDA considers the use of RWE to support regulatory decision-making for medical devices when the agency finds that the real-world data (RWD) used to generate the RWE are of sufficient quality to inform or support a particular regulatory decision. RWD may potentially be used to expand the labeling of a device and can come from a number of sources. Such data could potentially be used to support a switch from prescription to OTC use.

For more information, see:

Q: Are OTC devices searchable in the FDA’s medical device databases?

A: In the OTC – Over The Counter database for IVD Home Use Lab Tests, the FDA provides a searchable listing of OTC diagnostic tests and collection kits that the FDA has authorized for marketing.  

OTC medical devices are included in the FDA’s other Medical Device Databases, but these databases are not searchable by OTC or prescription (Rx) status.  

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.

For more information, see:

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

A: The FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” provides recommendations on human factors and usability engineering processes. The “Content of Human Factors Information in Medical Device Marketing Submissions” guidance provides recommendations on human factors information manufacturers should submit in a marketing submission.  

As discussed in these guidances, the outputs from the risk management process and usability requirements are included as part of determining design and development inputs. Manufacturers conduct a risk assessment to analyze and evaluate the risks associated with device use. If the results of the associated risk assessment indicate that users performing tasks incorrectly or failing to perform tasks (use errors) could cause or result in unacceptable risk to the patient or the device user, the manufacturer identifies appropriate risk controls. (See ISO 13485, Clause 7.3.3, incorporated by reference into 21 CRFR Part 820.)

Application of human factors engineering processes can play an especially critical role in identifying the hazards associated with the use of a medical device by lay persons. Human factors engineering considerations in the development of medical devices involve the three major components of the device-user system: (1) device users; (2) device use environments; and (3) device user interfaces. For an OTC device, the intended users could include lay persons such as people who operate devices on themselves to provide self-care and family members or friends who serve as lay caregivers to people receiving care in the home, including parents who use devices on their children or supervise their children’s use of devices.

Testing typically addresses the following:  

  • Inclusion of representative lay persons who perform selected tasks under conditions of simulated (not actual) use in an appropriately realistic environment.  
  • Inclusion of lay persons representative of the population of intended users, including the range of characteristics present within each user group.  
  • Inclusion of participants in the U.S. because studies performed in other countries may be affected, for example, by different units of measure used or language differences that change the way labeling and training are understood.  
  • Environmental factors: To the extent that environmental factors might affect users’ interactions with elements of the device user interface, incorporating such conditions into the simulated use environment (e.g., dim lighting, multiple alarm conditions, distractions, and multi-tasking) is relevant.  

The human factors engineering process ideally occurs 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 Applying Human Factors and Usability Engineering to Medical Devices (final guidance) and Design Considerations for Devices Intended for Home Use (final guidance).

For more information, see Applying Human Factors and Usability Engineering to Medical Devices (final guidance) and the relevant U.S. and international consensus standards, such as the following. For the current edition of the FDA-recognized consensus standards, see the FDA Recognized Consensus Standards Database.

  • ANSI/AAMI HE 75, Human factors engineering – Design of medical devices,
  • ANSI/AAMI/IEC 62366, Medical devices – Application of usability engineering to medical devices.
  • ANSI/AAMI/ISO 14971, Medical devices – Application of risk management to medical devices
  • IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
  • IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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 is simple, visible, concise, and easily understood by the lay person, with narratives or pictures where appropriate. The labeling also includes contraindications that explain why any individual should not use the device and includes clear warnings of all hazards. In addition, the labeling is intended to 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.

For more information, see:

Q: What are the cleaning or disinfection considerations for OTC devices?

A: Non-professional users do not have easy access to the cleaning or disinfection supplies that are readily available in health care facilities. OTC medical devices that are used by lay persons in the home should be designed to be cleaned or disinfected with readily available supplies and use of simple techniques. If an OTC device requires cleaning or disinfection prior to use, the labeling for the device should describe the methods for cleaning or disinfecting the device. For more information, see Design Considerations for Devices Intended for Home Use (final guidance).

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.

For more information, see:

Q: What is the mechanism for obtaining feedback from the FDA on the necessary data to support a premarket submission for an OTC device?

A: The Pre-Submission process provides the opportunity for a submitter to obtain the FDA’s feedback prior to an intended premarket submission, such as a premarket notification [510(k)] or De Novo classification request. In the Pre-Submission, the submitter can pose questions relevant to the planned marketing submission, such as whether a clinical study is recommended, or seeking feedback on clinical study endpoints, inclusion criteria, and follow-up duration where the study is intended to expand the current indications for use from prescription use only to OTC use.

For more information, see

Q: What are the requirements for clinical trials of OTC devices?

A: Clinical studies of devices, including OTC devices, must comply with the FDA’s human subject protection requirements in:

Sponsors of investigational studies for significant risk (SR) devices are required to get an approved IDE from the FDA before starting their study. For non-significant risk (NSR) devices, if an IRB finds that an investigational device study is NSR, the sponsor does not need to submit an IDE to the FDA before starting the study. For example, see Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Frequently Asked Questions about Medical Devices (January 2006) (PDF-266KB).

Clinical trial devices are subject to design and development requirements, including verification and validation. Verification and validation testing prior to initiating clinical trials may include testing to FDA-recognized consensus standards, such as those related to biocompatibility, risk management, software, and electrical safety. For additional resources, you may search for device-specific guidances on the Search for FDA Guidance Documents page. For additional information regarding clinical trial devices, see IDE Related Topics.

For information regarding the use of data from clinical investigations conducted outside the United States, see:

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.  

For more information, see:

Q: When are OTC digital health solutions or software regulated as devices?

A: An OTC digital health solution may contain software functions that are considered devices as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act and are subject to the FDA’s device regulatory oversight. Pursuant to section 520(o)(1)(B) of the FD&C Act, software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is excluded from the device definition in section 201(h) of the FD&C Act, as discussed in FDA’s guidance titled General Wellness: Policy for Low Risk Devices. To learn more about the regulatory considerations used to determine whether the FDA will regulate a certain software function, we recommend reviewing FDA’s Guidances with Digital Health Content and using the FDA’s Digital Health Policy Navigator. The Digital Health Policy Navigator was developed to aggregate the FDA's device digital health guidance documents and provides a user-friendly resource to help navigate the FDA’s existing policies and possible regulatory status of a given software function.  

Q: What considerations apply to OTC software devices or connected devices?

A: In general, software devices and connected devices, including those that may be OTC, raise a number of unique considerations, including software validation, cybersecurity, and interoperability. For FDA guidance documents containing recommendations for medical device software or connected devices, visit the Guidances with Digital Health Content webpage.

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