by Malia Tartt
ulu’s hit series “The Dropout” details Theranos founder Elizabeth Holmes’ effort to develop an at-home blood testing device. The series has many Americans considering how medical devices end up on the market. After all, The Regulatory Review estimates that the United States generates40% of worldwide revenue from medical device sales. Roughly thirty-two million Americans live with medical devices either implanted in their bodies or as part of their daily lives.
The U.S. Food and Drug Administration (FDA) regulates the medical device industry to ensure safe and effective products. Before a manufacturer or developer can sell a medical device in the U.S., they must prove to the FDA that it is reasonably safe andeffective. The FDA follows a five-step process for taking a medical device from idea to reality.
Step One, “Device Discovery and Concept,” is a crucial stage in the development because it determines the device’s pathway to market. During this stage, the FDA will classify a medical device into three categories based on the risk it poses. Class I medical devices (ex., bandages or latex gloves) pose the least risk. They are subject only to general controls, like good manufacturing practices and registration. Class II medical devices (ex., catheters or blood pressure cuffs) pose a higher risk to consumers. They are subject to controls like labeling requirements and device-specific testing. Class III devices (ex. pacemakers or breast implants)support or sustain life, are implanted in the body or pose an unreasonable risk of illness or injury. They are subject to the strictest controls.
During Step Two, “Preclinical Research,” researchers will build a device prototype to test in a lab.
Step Three, “Pathway to Approval,” depends entirely on the device’s risk classification. Class I and Class II devices can gain market access simply by comparing their device to one or more similar devices already on the market. Due to their potentially dangerous nature, Class III devices require premarket approval. Premarket approval requires independent scientific evidence to determine whether the device’s use outweighs its possible risks.
The FDA will review a device to determine if it is safe and effective enough to be placed on the market during Step Four, “FDA Device Review .”This stage depends on the device’s classification. It may include inspecting manufacturing laboratories to check for good manufacturing processes or consulting with an expert advisory committee. The FDA’s involvement does not end once it approves a product. New safety concerns may emerge once the device is on the market. Products are sometimes deemed unsafe or recalled, even after the FDA approves them.
During Step Five, “Post-Market Device Safety Monitoring,” the FDA closely monitors the device’s performance after approval. FDA officials may routinely inspect manufacturing facilities with or without notice. Additionally, programs like MedWatch allow the FDA to monitor the device’s ongoing safety and efficacy.
The FDA and consumers expect that this extensive process will eliminate dangerous devices from the market. Unfortunately, the reality is that the FDA recalls about 4,500 drugs and devices every year due to injuries, death and other adverse experiences that patients and physicians report.