If you are like most New York consumers, you probably assume that a Food and Drug Administration-approved product has been properly tested and is now considered safe. Unfortunately, that is not always the case. For example, about 90 percent of the medical products and devices that are on the market have been approved by the FDA through the agency’s 510(k) process.

But under a loophole in that process, a product that is ‘substantially equivalent’ to one that has previously been approved by the FDA must also be approved, automatically, no questions asked. Because this is the case even when that earlier product has been recalled or has otherwise been shown to be harmful, the loophole results in many defective products making their way to the market. To remedy this dangerous situation, a number of federal lawmakers are currently working to pass a law which would effectively close that loophole. Continue reading →