Clinical Researcher—February 2025 (Volume 39, Issue 1)
CHAIR’S MESSAGE
Christina Brennan, MD, MBA, FACRP, 2025 Chair of the ACRP Board of Trustees
The U.S. Food and Drug Administration (FDA) has evolved over the years from a small bureau originally based within the U.S. Department of Agriculture to a large agency now having responsibility for the safety, efficacy, and security of food, drugs, medical devices, cosmetics, tobacco products, and more. It is the oldest consumer protection agency in the U.S. government.
In the early 1900s, the movement for food and drug regulation began. In 1930, the agency was renamed from the Bureau of Chemistry to the FDA, and in 1968, it was moved to be based within what is now the Department of Health and Human Services. Although the FDA’s oversight of medical devices first came under the Food, Drug, and Cosmetic Act in 1938, the regulation of medical devices started in 1976.
The pathways for medical devices and drugs to reach the market are quite different, as illustrated below.
Drug Pathway
Medical Device Pathway
The medical device pathway offers more flexibility based on the risk level of the device. Lower risk devices can enter the market more quickly through the 510(k) pathways, while higher risk devices face a more rigorous process with clinical trials. Medical device clinical trials share some similarities with drug trials; they are designed to evaluate the safety and effectiveness of new medical devices in humans. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices.
A key distinction between drugs and devices lies in their interaction with the body. Drugs, primarily designed for therapeutic purposes, are metabolized and have a half-life, meaning they are eventually eliminated from the body. On the other hand, medical devices can be used as diagnostic tools or for therapeutic purposes and may remain in the body permanently.
Compared to drug trials, the specific phases and requirements vary on the device’s classification and intended use and regulatory pathway, as described below.
Early Feasibility Studies, often called pilot studies, are similar to first-in-human studies:
- Assess safety and feasibility
- Enroll 10 to 30 participants
Pivotal Studies (Similar to Phase II/III):
- Primary clinical evidence for safety and effectiveness
- Larger enrollment than EFS
- Could be with a control group or sham procedure
Post-Market Surveillance (Similar to Phase IV)
- Ongoing monitoring and surveillance
- Captures real-world experience, many participants to enroll
| Class | Risk | Examples | Safety/Effectiveness Controls | Regulatory Pathway |
| I | Low | Tongue depressors, hospital beds | General Controls
-With Exemption -Without Exemption |
Self Registration
Or 510(k) |
| II | Medium | Absorbable sutures, blood pressure cuffs | General Controls
-With Exemption -Without Exemption Special Controls -With Exemption -Without Exemption |
•Most class II devices are approved under a 510(k) pre-market notification submission.
•Few devices of class II are approved under Pre-market Approval (PMA) •10% to 15% of devices require clinical trials |
|
III |
Highest | Implantable pacemakers, coronary stents | General Controls
Special Controls Pre-market authorization |
PMAs
Almost all require clinical data |
In 2014, the FDA established the Early Feasibility Studies (EFS) program within the CDRH as an interactive early engagement pathway for developers of medical devices. An EFS is for investigating a device early in development; it enrolls a low number of subjects and can review the device concept early for safety and functionality. There is an opportunity early on to make device modifications if needed before moving on to a pivotal trial. Prior to the EFS program, testing of novel devices was often completed outside the U.S., often delaying U.S. physician clinical experience with, and patient access to, new products. Approximately 60 new EFS IDE submissions are reviewed each year by the FDA.
In 2015, the FDA established the Breakthrough Devices program to allow for expedited review of medical devices for effective treatment or diagnosis of life-threatening conditions.
The FDA regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide. Typically, 12 new or modified devices are approved, cleared, or receive marketing approval every business day.
Medical devices are everywhere around us, ranging from simple tools like tongue depressors to prosthetic limbs to complex implants like pacemakers, valves, and stents. The widespread use of these devices highlights the need for careful design and effective regulation to ensure patient safety.
**ACRP**
