Mar 14, 2016
Proposed legislation targeting the Food and Drug Administration’s medical device premarket review processes as well as the scope of the agency’s oversight over medical software are now closer to approval in the US Senate.
Three bills passed by the Senate Health, Education, Labor and Pensions Committee would specifically allow more types of devices to qualify for expedited US market access; utilize medical device premarket review processes more so than those for pharmaceuticals to review combination products; and limit or preclude FDA regulation of certain types of medical software.
Although these proposed bills must still be approved by the full Senate, they have drawn bipartisan support within the HELP committee, and legislators in the US House have already passed similar legislation. These new proposals—particularly expanded eligibility for the FDA priority review program—have been well received by the US medical device industry, and the opportunity to qualify for expedited FDA review would no doubt draw more premarket applicants to the world’s largest device market.
Legislation advancing through both houses of the US Congress would require “least burdensome” training of Food and Drug Administration staff involved in premarket reviews of medical devices.
Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration oversight.