The U.S. Food and Drug Administration is the agency that ultimately decides upon the safety of medical applications, both pharmaceuticals and devices, and approves their use by providers to the public. To do so, the FDA relies largely on data produced by clinical trials — what happens when the drug or device is actually used by a number of people — conducted when the product is considered by the manufacturer to be ready for public distribution.
But while clinical trials are always mandated for new drugs and involve hundreds of thousands of people, standards for devices — which can be anything from a heart valve to a breast implant, a replacement hip to an IUD, are more flexible.
A March 8 article in FinancialNewsMedia.com quotes an industry insider explaining,
“When studying medical devices, clinical trials may not be required, depending on the risk stratification (or class) of the device. Generally, the total number needed to treat to demonstrate safety and effectiveness in a device trial is in the hundreds rather than the thousands needed in drug trials,” the insider says.
The FDA allows Independent Review Panels to regulate the way research is conducted (with safety of the human subjects the main priority) and can approve or disapprove a researcher or company’s methodology, monitor changes as the research progresses and expedite the approval process if warranted. The agency currently regulates approximately 1,700 devices — everything from simple bandages to breast implants to heart valves to dialysis machines — now available for use by the American public.
The medical devices industry, which is constantly growing and evolving as new technologies are developed, is a significant contributor to the U.S. economy, according to Forbes, representing a market of more than $400 billion.
