The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported legislation that would streamline the FDA’s evaluation process for medical devices, one of seven biomedical innovation bills currently advancing to the full Senate for consideration.
The FDA Device Accountability Act of 2015 (S. 1622), sponsored by Sens. Richard Burr, R-N.C., and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors.
The legislation aims to reduce regulatory hurdles for the approval of medical devices by guaranteeing consistent application of the least burdensome review requirements, mandating employee training on the least burdensome approach, allowing central institutional review board approval and requiring the FDA to explain how the least burdensome requirements were considered and applied in any approval process.
“In response to the concerns of this committee about the consistency of the application of ‘least burdensome,’ our bill includes provisions to help ensure the letter and spirit of least burdensome requirements are realized,” Burr said in remarks during the meeting.
The bill requires that any FDA employee involved in the premarket submission process of medical devices receive training to make the approval of those devices easier. Currently, the FDA is required to consider the least burdensome appropriate means for a device sponsor to demonstrate the effectiveness of a device or its substantial equivalence to an approved device.
The ombudsman for any applicable unit of the FDA must conduct an audit of the training on least burdensome requirements.
“Our bill also permits device innovators to work with local or central [institutional review boards], as in the case with drug clinical trials,” Burr said. “Providing innovators and the agency with this option is another way our bill is supporting more timely access to medical devices. That’s a good thing.”
The bill also calls for the FDA to re-examine its guidance on the approval of Clinical Laboratory Improvement Amendments (CLIA) waivers for diagnostic tests administered at the point of care, including physicians’ offices and EDs.
“In response to concerns that the current FDA guidance on CLIA waivers has resulted in significant regulatory challenges, our bill instructs the FDA to issue new guidance on the regulation of CLIA-waived tests,” Burr said.
Burr said the bill will ensure Americans are able to benefit from new medical devices in a timely manner.
“Technology is evolving at a pace that outpaces anything that any of us could have imagined even 2 years ago,” Burr said. “We need that fast change in health care if we’re going to begin to get control of costs. But more importantly … it’s about changing the health outcomes of the American people. That’s where our focus needs to be.”
The bill was one of seven bipartisan pieces of legislation under consideration during the executive session, designed to serve as companion legislation to the House-passed 21st Century Cures Act legislation.
In a statement, the Advanced Medical Technology Association (AdvaMed) commended the committee’s work on the legislation.
“[The recent] committee vote in favor of the FDA Device Accountability Act brings legislation that will help ensure more timely patient access to the latest medical innovations one step closer to enactment,” JC Scott, senior executive vice president for government affairs at AdvaMed, said in a press release. “This legislation includes common sense reforms to eliminate redundant requirements at the agency and to help improve the agency’s medical technology review process.
“AdvaMed commends … the lead sponsors of the FDA Device Accountability Act and Senate [Health, Education, Labor and Pensions] Committee Chair Lamar Alexander, R-Tenn., and ranking member Patty Murray, D-Wash., for their leadership in moving this important legislation forward,” Scott said. – by Regina Schaffer
- Burr R, et al. U.S. Senate Committee on Health, Education, Labor and Pensions Executive Session; Feb. 9, 2016; Washington, D.C.
- S.1622 – FDA Device Accountability Act of 2016. Library of Congress. Available at https://www.congress.gov/bill/114th-congress/senate-bill/1622. Access May 17, 2016.
Disclosure: The senators report no relevant financial disclosures.