• Provision Consulting Group

FDA, OTC Medical Devices Q&A for Device Manufacturers

Apr 20 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. 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?


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.

Examples include:

  • Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use Final Guidance (final guidance)

  • Final Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s (final guidance)

  • Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions (final guidance)

  • Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (final guidance)



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


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.

For more information, see:

  • Deciding When to Submit a 510(k) for a Change to an Existing Device (final guidance)



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 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 or PMA may be required.


For more information, see:

  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (final guidance)



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?


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:

  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (final guidance)

  • Real-World Evidence



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


In the OTC – Over The Counter database for IVD Home Use Lab Tests (Over The Counter) 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 Rx status.



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


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:

  • Design Considerations for Devices Intended for Home Use (final guidance)

  • Applying Human Factors and Usability Engineering to Medical Devices (final guidance)



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


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).


Human factors testing should include label comprehension and self-selection performance evaluations to demonstrate that the intended lay users can understand the package labeling and correctly choose the device for the indicated use. For example, see Special Controls in 21 CFR § 878.4420 for electrosurgical devices for OTC aesthetic use.


For more information, see Applying Human Factors and Usability Engineering to Medical Devices (final guidance) and the relevant U.S. and international standards, such as:

  • ANSI/AAMI HE 75:2009, Human factors engineering—Design of medical devices,

  • ANSI/AAMI/IEC 62366:2007/(R) 2013, Medical devices—Application of usability engineering to medical devices.



Q: What are the labeling considerations for OTC devices?


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.


For more information, see:

  • Design Considerations for Devices Intended for Home Use (final guidance)

  • Guidance on Medical Device Patient Labeling (Final guidance)

  • Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices.



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


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?


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:

  • Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (final guidance)

  • De Novo Classification Process (Evaluation of Automatic Class III Designation) (final guidance)



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


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

  • Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (final guidance)



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


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

  • Informed consent and safeguards for children in research in 21 CFR Part 50,

  • Institutional Review Board (IRB) requirements in 21 CFR Part 56,

  • Investigational Device Exemptions (IDE) requirements in 21 CFR Part 812,

  • Financial Disclosure for Clinical Investigators requirements in 21 CFR Part 54 and

  • Any other applicable regulations, including, where applicable, the regulations at 21 CFR Part 809 (In Vitro Diagnostic Devices For Human Use).

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 controls, including design 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 analysis, 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 design control requirements for clinical trial devices, see IDE Related Topics.


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

  • Acceptance of Data from Clinical Investigations for Medical Devices

  • Final Rule, Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices, 83 FR 7366 (February 21, 2018)

  • Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions (final guidance)



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


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:

  • Final Rule, Unique Device Identification System, 78 FR 58786 (Sept. 24, 2013)

  • Unique Device Identification System (UDI System)




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SOURCE :

https://www.fda.gov/over-counter-otc-medical-devices-considerations-device-manufacturers