Recently, three United States Senators introduced legislation to amend the U.S. Food and Drug Administration’s (FDA) post-market watch of medical devices. Currently, the FDA may approve moderate-risk devices through the 510(k) process as long as the product is found to be similarly safe and effective as another product that is already on the market. This is considered a fast-track approval process.
However, the new bill would allow the FDA to require companies to submit post-market information in order to gain approval for moderate-risk medical devices. Furthermore, the FDA could order companies to administer additional safety studies after devices are approved.
Under the proposed legislation, the FDA would also be required to evaluate recalls and decide whether they were executed effectively.
Ideally, the newly proposed bill would mean safer medical devices for patients, offering less hassle and less chance of medical complications for patients and consumers. We welcome all efforts by lawmakers and the FDA to increase the safety of patients who use those medical devices.