Tag: Implantable device

According to the U.S. Food and Drug Administration (FDA), medical devices are defined as instruments, apparatuses, implants, or similar articles for medical purposes. A port-a-cath, also known as a port catheter, fits squarely within this definition, serving as a crucial tool for long-term patient care.

According to estimates based on past National Health Survey data, roughly 8-10% of Americans live with some form of medical implant. Understanding the official FDA definition of a medical implant is crucial for manufacturers, clinicians, and patients alike, as it dictates the level of regulatory oversight and determines a device’s safety requirements.

Did you know that millions of Americans live with medical implants? This guide explores the diverse world of implanted devices and precisely **what counts as a medical implant**, from temporary sutures to permanent cardiac regulators, providing clarity on this vital medical topic.