The Food and Drug Administration (FDA) was founded in 1906, but it wasn’t until 1938 in the wake of the Sulfanilamide Disaster that Congress passed the Federal Food, Drug and Cosmetic Act, empowering the agency for the first time to evaluate and ensure the safety and efficacy of drugs in the U.S. Then in 1976, following a spate of deaths caused by defective contraceptive products, the FDA’s authority was again expanded to include oversight of medical devices.
In the interest of balancing public safety while avoiding overregulation that could stifle innovation, Congress mandated two separate processes for devices seeking FDA approval. The more stringent process is known as premarket approval (PMA), which is roughly analogous to the agency’s process for evaluating new pharmaceuticals: manufacturers submit new medical devices for exhaustive testing to determine whether they safely achieve their intended effect. PMA is both expensive and time consuming, which is why many manufacturers instead opt for the significantly cheaper and faster pathway known as the 510(k) process.
510(k) is similar to the FDA’s process for approving generic medications. Under the 510(k) process, device manufacturers are exempted from clinical trials and even demonstrations of safety and efficacy on the basis that the product in question is substantially similar to other devices — known as predicates — already on the market.
When it was originally conceived, the 510(k) process was intended for products like surgical gloves and other non-critical medical tools and devices. But the early 2000s saw the beginning of an era of mass deregulation and before long, 510(k) clearances were granted for everything from metal hip implants to transvaginal mesh. Today, the vast majority of new medical devices are approved through the 510(k) process, while the more thorough PMA process accounts for only 1 percent of clearances granted.
This is the first half of a two-part explainer on the FDA’s 510(k) process. Check out part two for a brief overview of the impact 510(k) approvals have had on the quality of medical care in the U.S.