Post-Market Device Issues

FDA’s postmarket regulations follow a medical device from production and processing to packaging and distribution to immediate and long-term performance in the market. Medical device manufacturers must establish and maintain a comprehensive “quality system” to ensure their devices are manufactured consistently to specifications set by FDA, and they must establish and maintain thorough reporting mechanisms to detect, identify and mitigate any device-related problems.

Clinical Trials and Medtech

The question is often asked: “Why don’t all new medical devices require clinical trials the same way for a new drug?” The simple answer is that they are not needed to determine the safety and effectiveness for the vast majority of devices.

Clinical trials are required for high-risk devices and those that are “really novel,” Dr. Susan Alpert explains, “where we don’t understand the safety or the benefits.”

510(k) Process / 510(k) Clinical Testing

Much of the innovation that occurs in the medical technology realm is the result of incremental progress. Based on feedback from physicians or patients, for example, a company may decide to modify an existing product for ease of use or greater comfort. Advances in materials science or other disciplines may prompt a company to change a product to increase durability or longevity.

Regulation of Medtech vs. Drugs

Comparing medical devices and pharmaceuticals is like comparing apples and oranges. Drugs interact with a patient metabolically, immunologically, or pharmacologically. As Susan Alpert explains, “Pharmaceuticals are discovered: you don’t know much about them until you start using them and start evaluating them in actual patients.”

Risk and Medtech

No medical intervention -- whether it involves a surgical procedure, a hospital stay, prescription pharmaceutical, medical device or OTC drug – will ever be entirely risk free. And despite the best efforts of industry and FDA, no amount of testing or review will be able to anticipate and prevent every adverse event or negative consequence. “That’s not the world we live in,” says Dr. Susan Alpert.