Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Inside Health Policy's FDA Week, in “Draft Bill Shows Congress’ Struggle to Define FDA’s Role in Medical Software,” by Erin Durkin.
Following is an excerpt:
The draft update to the “Sensible Oversight for Technology which Advances Regulatory Efficiency Act,” which also carries the name of Rep. Gene Green (D-TX), splits software into two different categories -- medical and health -- instead of the three categories included in the earlier bill. “It creates a dividing line between software that FDA will regulate and software that should be unregulated,” said Bradley Merrill Thompson, an attorney at Epstein Becker & Green.
The draft also defines device accessories similarly to how they are defined in an FDA guidance released last week, but lawmakers go a step further and ask FDA to classify such products instead of putting the onus on industry to request down classifications, according to Thompson. The draft bill also calls for FDA, with input from stakeholders, to draft regulations clearly laying out the agency's policies on medical software classification and the related premarket and postmarket requirements for such software.
“In the prior version, they divided the entire universe of health software into three buckets,” said Thompson. “The first bucket, medical, was to be regulated by FDA, but not much more was said about it. The second bucket, health, included lower risk software including clinical decision support software. The third bucket was clinical software which included mostly administrative software for scheduling and so forth. The definitions were pretty complicated, and the legislation itself treated the second and third categories the same, other than observing that there could be regulatory requirements put in place later to match the level of risk.”
