New FDA Rules Could Change Product Liability, Consumer Protections

The U.S. Food and Drug Administration is taking a close look at how it handles approval for medical devices in today’s fast-paced medical industry. A Feb. 19 report in the Insurance Journal shows that FDA staff is saying they need to change the rules on approval for different kinds of medical devices, which may lead to more regulation of these products.

At issue, according to the report, is an accelerated process currently used for devices that have some similarity to other devices already on the market and approved by the FDA.

FDA officials say it can be difficult to measure how similar a new product may be to others, and that this lack of clarification can cause significant problems related to the approval of new devices.

Many who are making medical devices for the market urge the FDA not to conduct a major overhaul of their policies, saying this could create deterrence for new technologies that can help heal the public.

The FDA division in charge of this approval process, called 510(k), must figure out a way to thoroughly evaluate medical devices to make sure they are safe for the market. Consumer advocacy groups claim that loopholes like the accelerated process can allow potentially harmful products to slip through to the market.

A look into the industry shows that many companies are submitting a series of similar products and devices to the FDA, hoping that newer engineered products will be judged similar to those already on the market. One problem is that these devices can include more extreme treatment methods, meriting further investigation by the regulatory agency. Consumer advocates point to significant cases of recalls within the medical device industry to show that some FDA approved medical devices are later found unsafe for public use. Those involved in handling product liability insurance for large medical device manufacturers will want to be acquainted with any future changes in FDA approval. Experts in product insurance law also need to know how recalls will affect a company and how class action suits or other events can change realities within an industry.