The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as duodenoscopes.
The legislation gives FDA the authority to refuse or deny a 510(k) submission based on whether the manufacturer’s cleaning instructions work in real-world conditions, and whether the manufacturer can provide satisfactory data showing the device can be reliably decontaminated between uses.
It also requires the agency to prioritize updates to its guidance that will clarify when manufacturers are required to seek FDA clearance to market modified devices.
S. 2503, known as the Preventing Superbugs and Protecting Patients Act, was approved in February as part of the committee’s biomedical innovation agenda.
The approval marks the first step toward creating a Senate counterpart to the House 21st Century Cures Act. However, the Senate version is introducing legislation in three different markup sessions rather than one measure.
The legislation follows an ongoing investigation into contaminated devices linked to antibiotic-resistant infections at Virginia Mason Medical Center in Seattle and nationwide.
In February, the FDA signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria.
In January, an investigation led by Murray determined that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to the duodenoscopes.
Murray said the investigation also found evidence that certain manufacturers failed to properly test whether the device could be cleaned reliably between uses. Further, there was evidence that certain manufacturers failed to seek necessary FDA clearance before marketing devices with modifications that affected the safety and effectiveness of those products.
Following the investigation, Olympus recalled the scopes, and the FDA then cleared a newly redesigned duodenoscope.
The legislation is one of seven bills as part of the biomedical innovation agenda. The second of three markups was scheduled for March 9, when five more biomedical innovation bills were considered. A third and final markup was slated for April 6 to complete the Senate’s version of the measure.
Stay up to date on regulatory stories like this one by subscribing to the The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation.