FDA Medical Device Research

The U.S. Food and Drug Administration regulates the development and marketing of medical devices, including their testing in human research participants. FDA regulations for IRB oversight and monitoring of this category of research are complicated and differ from the more commonly applicable regulations governing protection of human subjects in research.

How does FDA define “medical device?”

In Section 201(h)(1) of the Food, Drug, and Cosmetic Act, FDA defines a medical device as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

This definition includes a wide range of items, from tongue depressors to MRI scanners. While it is common for medical device research to be conducted in clinical settings such as hospitals and academic medical centers, this type of research can also occur at universities where research opportunities in clinical settings are more limited. Examples of medical device research that may be undertaken at UTC include development and testing of:

• Mobile medical apps, artificial intelligence/machine learning algorithms or software for use in health applications
• Items for use in providing physical therapy to persons with functional impairments
• Implants or prosthetic devices
• Modified versions of existing FDA-approved medical devices, such as walkers, wheelchairs, braces, etc.

When do FDA medical device regulations apply?

The FDA regulations apply when:

• A medical device will be assessed for safety and/or effectiveness in one or more healthy individuals or patients, AND
• The device has not been FDA cleared or approved, AND
• The device is not being used exclusively for diagnostic purposes that meet FDA exemption criteria

When in doubt, seek guidance. Failing to meet regulatory requirements prospectively can lead to costly delays in development and marketing efforts, or fines if devices are marketed without documented approvals and evidence of compliance with applicable regulations.

What should I do if I am planning to conduct medical device research?

1. Seek guidance early and often. Consult UTC IRB staff at [email protected] in the initial stage of developing a research agenda involving medical devices. Review guidance and resources from FDA and other sources (see list below).
2. Allow sufficient time to learn about regulations and address compliance requirements. The regulatory requirements can be extensive based on the FDA risk classification of the device, and can apply to prototyping and manufacturing processes, device labeling, and other aspects of product development beyond testing in human beings. Of note, regulations and guidance related to mobile medical apps, AI/machine learning, and augmented/virtual reality are periodically updated by FDA as technological capacities and regulatory priorities evolve.
3. Identify any intellectual property or contributions by collaborators that may require management. The University of Tennessee Research Foundation can provide guidance and assistance in this area.
4. Identify any liability concerns that may apply, e.g., if students will be on the research team or involved in device development.

Resources

GETTING STARTED
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) – Investigational Device Exemption – includes a decision tree and information about risk assessment prior to IRB review

STRATEGIC PLANNING – MEDICAL DEVICE R&D
Building a team of stakeholders and understanding the regulatory pathway: “Strategic Planning and Costs of FDA Regulation”

SELECTED FDA RESOURCES AND GUIDANCE

• FDA Device Advice – provides comprehensive education and guidance on medical device regulations
• FDA Digital Health Center of Excellence – guidance on the use of AI, machine learning, and augmented/virtual reality in health applications
• FDA Guidance: How to Determine if Your Product Is a Medical Device
• FDA Guidance: SR and NSR Medical Device Studies
• FDA Guidance: Classify Your Medical Device
• FDA FAQ on Investigational Device Exemption