In hoping to ensure that new medical devices reflect modern safety and effectiveness features, the FDA is revising its process for approving medical devices. In modernizing the approval process, the FDA wants to compel companies to base products on devices that are not older than 10 years.

For many years, the Food and Drug Administration’s (FDA) process for approving medical devices has been widely criticized. Under current regulations, manufacturers may launch new products based on similarities to products, which may be decades-old, instead of conducting new clinical testing. Also, the FDA has often failed to detect defects and other problems with medical products leading to class action lawsuits.

Approval for a medical device depends on its risk classification. These devices are classified based on the level of control necessary to provide reasonable assurance of its safety and effectiveness. Thus, they are divided into Class I, Class II, or Class III, with Class III being the highest risk and Class I the lowest risk.

Currently, approvals of medical devices are analyzed under guidelines adopted in 1976 under the Medical Device Regulation Act. The FDA announced it was revising the process less than 24 hours after the publication of a worldwide investigation into the safety of medical devices. Based on events reported to the FDA over a 10-year period, the International Consortium of Investigative Journalists found that more than 1.7 million injuries and nearly 83,000 deaths were suspected of having links to medical devices.

Under the 1976 regulations, more than 95 percent of medical devices are cleared for use by Americans. While new pharmaceutical drugs are required to undergo rigorous testing, including patient studies, medical devices must only demonstrate that they are similar to other devices already being marketed. Thus, only a very small number of new medical devices is subjected to clinical testing to verify safety and effectiveness.

Some experts believe Congress originally intended for the current, streamlined process to be a temporary means of grandfathering in thousands of low-to-moderate risk devices. Instead, the process was never phased out and became the normal path to device approval. Some of the FDA’s changes may take years to implement, as well as require Congressional action to promulgate new guidelines and regulations.