News Feature | February 11, 2016

Senate Committee Advances Bills To Facilitate Device Trials, Improve Safety Of Reusable Devices

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Senate Health, Education, Labor & Pensions (HELP) Committee in a preliminary meeting advanced two key bills affecting the medical device industry, part of a larger raft of counterpart legislation for the House of Representatives' 21st Century Cures Act that attempts to overhaul the U.S. Food and Drug Administration’s (FDA) regulatory framework.

The FDA Device Accountability Act of 2015 (S. 1622) seeks "to ensure Americans benefit from new medical devices more quickly by reducing unnecessary burdens in device evaluations and streamlining the review process for clinical trials" and to modernize "the regulation of diagnostic tests — creating a path for rapid diagnostics," states the announcement from the office of the HELP chairman Lamar Alexander (R-Tenn.).

Introduced last year by U.S. Sens. Richard Burr (R-N.C.) and Al Franken (D-Minn.), the bill specifically calls for the U.S. Food and Drug Administration (FDA) to train employees who review premarket submissions of medical devices on least burdensome requirements, and requires the agency to conduct an audit of said training. The bill also lifts the restriction for the Institutional Review Board responsible for reviewing the plan for the clinical testing of a medical device to be local to the facilities where the testing will be conducted, instead allowing sponsors to utilize centralized institutional review boards (IRBs) to seek approval in device trials. The bill also requires FDA to revise its guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.

In a statement, AdvaMed lauded the Senate's support for the bill, "This legislation includes common-sense reforms to eliminate redundant requirements at the agency and to help improve the agency’s medical technology review process. Specifically, the bill will require additional training and oversight so FDA reviews are done efficiently and expeditiously; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients."

The Preventing Superbugs and Protecting Patients Act (S. 2503), meanwhile, seeks to further encourage and clarify that the FDA requires cleaning and validation data for reusable medical devices, and to direct the FDA to clarity when device changes require regulatory clearance, according to the HELP press release. Specifically, it requires FDA to identify and publish a list of reusable devices or types of devices, including their labeling and instructions for use, cleaning, disinfection, and sterilization. The legislation seeks to address the rising incidence of lethal patient infection due to contaminated duodenoscopes and other devices.

According to Alexander, the Senate is doing its part in pushing for reform the current regulatory environment to benefit more Americans. “The House has completed its work on the 21st Century Cures Act, the president has announced his support for a Precision Medicine Initiative and a ‘cancer moonshot’ — and with this bipartisan action in committee today, we’ve shown the Senate’s potential to be the vehicle that turns these groundbreaking ideas into law this year to help improve the lives of nearly every single American,” he stated in the release.

The two pieces of legislation impacting the device industry are in addition to five more bills the Senate committee passed to kick off its Biomedical Innovation Agenda. These bills pertain to strengthening biomedical and epidemiological research, as well as improving health IT infrastructure. Per RAPS Regulatory Focus, these bills are:

  • Next Generation Researchers Act (S. 2014), to help attract more talented young scientists to the National Institutes of Health (NIH)
  • The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800), to require the National Center for Medical Rehabilitation Research (NCMRR) to update a comprehensive research plan for rehabilitation research
  • Advancing Research for Neurological Diseases Act of 2015 (S. 849), to help the CDC expand infrastructure and activities to track the epidemiology of neurological diseases
  • Improving Health Information Technology (S. 2511), which deals with a host of health IT provisions, particularly around electronic health records.

The HELP committee is scheduled to tackle five more related bills during a meeting on March 9, 2016.