Under current law, the U.S. Food and Drug Administration is required to approve a medical device or similar product if it is similar to a product that have already been approved by the agency. This means that many products are being put out on the market despite the fact that they have undergone no human testing to ensure their safety. Now, several federal lawmakers have introduced a bill that would effectively close that loophole and require that all products undergo individualized testing before being approved by the FDA.

The main issue with the loophole, the legislators say, is that even dangerous or defective products can be used as "substantial equivalents" to new products being submitted for FDA approval. This means that new devices are approved based on their similarity to products that have been recalled or have otherwise been proven to be harmful.

One of the most recent examples of the potential for harm caused by the loophole is the approval of vaginal mesh products. When Johnson & Johnson and other manufacturers of vaginal mesh submitted the product to the FDA, they were approved based on the previous approval of a mesh that was manufactured by Boston Scientific in the 1990s. This was despite the fact that the Boston Scientific mesh was recalled for safety issues in 1999.

Under the law as proposed in the U.S. House of Representatives, situations like this would no longer arise. The bill would allow the FDA to withhold its approval if the past device were removed from the market for safety concerns. It would also require the FDA to review previously approved products to determine whether they would still receive approval under the new law.

Source: Bloomberg, "Democrats Want to let FDA Block Medical Devices Tied to Safety Recalls," Alex Nussbaum, Feb. 2, 2012