Publications

The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators, and others. Additionally, it is important that clinical trials include diverse populations that reflect the intended use population. In general, to achieve an unbiased estimate of treatment effect in the general population, sponsors should develop a strategy to enroll diverse populations including representative proportions of relevant age, racial, and ethnic subgroups, which are consistent with the intended use population of the device. This guidance includes recommendations and considerations to assist sponsors in developing such a strategy. FDA recognizes the practical challenges in achieving the appropriate enrollment of diverse populations. This guidance includes recommendations to overcome barriers to enrollment in order to balance these recommendations with least burdensome principles.

This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The purpose of this guidance is to outline the FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The primary intent is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and that data from such studies is appropriately analyzed by sex. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others.

The purpose of this guidance is to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. Using standard terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data is collected consistently. The recommended standardized approach is based on the Office of Management and Budget (OMB) Directive 15 and developed in accordance with section 4302 of the Affordable Care Act, the HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status, and the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan. This guidance lists the OMB categories for race and ethnicity and describes FDA’s reasons for recommending the use of these categories in medical product (drugs, biologics, and devices) applications. In addition, this guidance recommends a format for collection of race and ethnicity clinical trial data that are submitted in standardized data sets per the Study Data Tabulation Model, in the electronic Common Technical Document (eCTD), and as specified in FDA’s Guidance on providing regulatory submissions in electronic format.

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). (1) This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products. (2)

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions, including those intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, from the definition of device in section 201(h) of the FD&C Act. Section 520(o)(1)(B) of the FD&C Act, states that 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 not a device under section 201(h) of the FD&C Act.

This guidance clarifies FDA’s interpretation of this provision and its application to general wellness products.

1: This guidance does not change or rescind any requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or any applicable regulations. This guidance also does not preclude FDA from consulting with the Consumer Product Safety Commission (CPSC) as to whether a general wellness product is a consumer product under CPSC’s authority or a device. FDA may coordinate with other agencies and authorities, such as the CPSC, to determine jurisdiction over products. If a product is a device under section 201(h) of the FD&C Act, it is generally excluded from CPSC’s authority over “consumer products” under the Consumer Product Safety Act (15 U.S.C. § 2052(a)(5)(ii)(H)). However, CPSC and FDA may both have jurisdiction over certain medical devices under other statutory authorities the CPSC administers.

2: For determinations on combination products, contact the Office of Combination Products at combination@fda.gov. See 21 CFR 3.2(e) for the definition of a combination product.

Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.

FDA is issuing this guidance to describe the policies FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3), as created by section 3051 of the 21st Century Cures Act (Cures Act), amended by section 901 of the FDA Reauthorization Act of 2017, and amended by Section 3001 of the SUPPORT for Patients and Communities Act  (the SUPPORT Act) (the “Breakthrough Devices Program”). The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. In addition, consistent with our obligations under the SUPPORT Act, the Breakthrough Devices Program may also be available for certain non-addictive medical products to treat pain or addiction (FD&C Act section 515B (21 U.S.C. 360e-3)). The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Today, CDRH is announcing that we will hold a virtual public meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on February 2, 2024 to discuss pulse oximeters.

The meeting will include discussions about a new approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity. The Committee will also discuss the type and amount of data that should be provided by manufacturers to the FDA to evaluate the performance of pulse oximeters submitted for premarket review, including prescription and over-the-counter indications, and labeling considerations, to ensure pulse oximetry is equitable and accurate for all patients.

Additionally, today the agency published a discussion paper, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity. Our hope is that this discussion paper and request for feedback will help to engage stakeholders and obtain public comment about concerns with pulse oximetry before the upcoming virtual public meeting. These actions were informed by the discussion from the November 2022 meeting of this advisory committee where stakeholders shared information and perspectives about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation.

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.

These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.

The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.

ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.

If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard.

NOTE 1 See also 4.2 of the general standard. “The general standard” is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance.

ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.

ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use.

ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.

NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.

ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.