Saying they want to limit unnecessary red tape, 4 senators have introduced legislation designed to get medical devices to market more quickly and safely.
The sponsors said the Patient Access to Medical Innovation Act (S 1865 [http://thomas.loc.gov]), introduced November 15, will promote the development of devices to treat patients with rare diseases, help improve the approval process for medical devices by allowing the Food and Drug Administration to more easily consult with experts, and lift the current profit cap on “humanitarian use devices”—devices that treat rare conditions—that go through a special approval process.
Mitka M. Speeding Device Approval. JAMA. 2012;307(2):134. doi:10.1001/jama.2011.1931