According to Ed Markey, D-Mass, the FDA needs stricter regulation of medical devices and to end the 510(k) pathway to approval. As a result of this belief, the congressman introduced the Safety of Untested and New Devices Act (SOUND) to close the 510(k) pathway, or as Markey refers to it, the regulatory loophole. This act aims to “ensure that new medical devices are not cleared by the FDA if they are based on a product that was recalled because it caused serious harm to patients,” according to the press-release.