Medical Device and Radiological Health Regulations Come of Age

Article excerpt

Each day when people put in their contact lenses, test their blood sugar levels, turn on their TVs, cook their meals, or punch a button on their cell phones, they are using products regulated by the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The CDRH protects Americans with safeguards that enable them to go about their daily lives knowing that these medical devices and radiological products are reasonably safe to use and that they work as intended.

By way of distinction, some radiation-emitting products, such as X-ray machines and computed tomography (CT) scanners, are medical devices because they are used in medical procedures. Other radiation-emitting products, such as TVs and microwave ovens, are not used medically, and therefore, are regulated by the FDA under a different law.

Medical devices are classified and regulated according to their complexity and degree of risk to the public. For example, devices that are life-supporting, life-sustaining, or implanted, such as pacemakers, must receive FDA approval before they can be marketed.

But medical devices haven't always come under such scrutiny. In fact, it wasn't until the late 1970s that the FDA actually gained authority to preapprove medical devices under the 1976 Medical Device Amendments. This law joined a separate law already in existence, the Radiation Control for Health and Safety Act of 1968, which authorized the agency to reduce unnecessary radiation from medical and non-medical electronic products.

Additional laws have, over time, mandated the reporting of adverse reactions to medical devices, post-market monitoring of implants and other devices that pose a serious health risk, recall of dangerous medical devices, and certification and annual inspection of mammography facilities.

The long legal journey toward medical device regulation and radiological health protection--and ultimately the 1976 Medical Device Amendments--begins with the Pure Food and Drugs Act of 1906.

The 1906 act marked the start of federal food and drug legislation designed to protect Americans against threats from harmful substances and deceptive practices. While medical devices were not put into the act, no one could have imagined the ways in which medical device technology would grow, change and, like food and drugs, need to be regulated during the coming years.

A Flood of Fraudulent Contraptions

The earliest recorded fraudulent medical device marketed in the United States was Dr. Elisha Perkins' patent tractors in the late 1700s. Perkins developed two rods of brass and iron about three inches long and sold them throughout the country, claiming they eliminated disease from the body. Even our nation's first president, George Washington, is reported to have purchased a set for his family. Within 10 years of Perkins' death in 1799, the device was exposed as a fraud.

Despite such occasional deceptive enterprises, President Theodore Roosevelt saw no need to ask for legislation concerning medical devices 200 years later, when the Pure Food and Drugs Act was enacted. Devices used by the doctors of his day, such as stethoscopes and scalpels, were comparatively simple, and any hazards or defects were readily apparent. Such devices stood at the edge of medicine--helpful but not essential--and therefore posed little real or perceived threat.

But by 1917, fraudulent medical devices, such as nose straighteners, height-stretching machines, and heated rubber applicators advertised as a cure for prostate gland disorders, began flooding the market. It was clear to the FDA that the law should be expanded to include agency authority over medical devices. In its annual report to Congress that year, the FDA stated that the 1906 act "has its serious limitations ... which render it difficult to control ... fraudulent mechanical devices used for therapeutic purposes."

Radiation added to the problem. …