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.

  • First, the Advancing Breakthrough Devices for Patients Act of 2015 would expand the FDA’s priority review program to include innovative medical devices beyond only those in the Class III category. Device sponsors may request that the FDA determines whether their product qualifies for priority review; if the agency affirms that the device is eligible, that device undergoes expedited premarket review.
  • Second, the Combination Product Regulatory Fairness Act of 2015 would address the complex US market registration route for combination products that share both medical device and pharmaceutical characteristics. The legislation would prohibit FDA reviewers from determining a combination product’s primary mode of action based only on whether the product involves a chemical action in or on a patient’s body. Agency reviewers would also have to provide additional justifications in decisions where they do not designate combination products as devices.
  • Third, the Medical Electronic Data Technology Enhancement for Consumers Health Act or MEDTECH Act would exclude various types of healthcare-related software from FDA medical device regulations. The agency has already indicated little to no interest in regulating many of these products in previous guidances, so the MEDTECH Act would codify this approach. Types of software for exclusion would include administrative software used by healthcare providers, electronic patient records and some types of clinical laboratory testing and medical recommendation 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.


  • Stewart Eisenhart