The Full Spectrum Blog

If you work in health care or as a communications partner to a medical device manufacturer, chances are very high that you are familiar with the 510(k) process. Yet, the average patient who benefits from the medical technology approved through this process each year may know very little about it.    

All medical devices must go through the Food and Drug Administration (FDA) for approval. The Medical Device Amendments Act of 1976 established a regulatory framework that would classify all devices based on their complexity and the degree of risk to the public. This legislation made it easier for manufacturers to bring simpler products to market like tongue depressors, elastic bandages and gauzes. Other devices like medical imaging equipment, endoscopes and dialysis catheters, for example, are subject to the FDA's 510(k) or premarket clearance of devices that examines whether a device is "substantially equivalent" to a predicate or existing device.  The FDA also determines whether additional clinical testing is needed before the device can be sold in the U.S. While originally designed as the exception to the approval rule, the 510(k) process has now become the norm. In fact, approximately 90 percent of medical devices in the U.S. have been evaluated by the FDA through this process.

Today with the majority of devices going through this process, the 510(k) is facing scrutiny from within the FDA itself, advocate groups and lawmakers on Capitol Hill who are questioning whether this process, as it currently stands, still provides safe and effective devices to consumers. (more...)