The Consumers Union (CU) is getting involved in the debate over the medical device approval process, asking Congress to bolster FDA’s standards for allowing a device on the market. The consumer advocacy group wants the agency to take a much stricter approach with regard to “all implantable and life-sustaining medical devices,” and to strengthen its postmarket surveillance system.

“Lax medical device approval standards are putting patient lives at risk,” Lisa McGiffert, manager of CU’s Safe Patient Project, said in the release. “The current system has allowed FDA to fast-track approval of more than 90% of new medical devices based on whether they are similar to other devices already on the market and without clinical trials that show the devices are safe and effective. It’s time to strengthen the federal law on medical devices, not scale back oversight at the expense of patient safety.”

The group sent a letter to Congress in November in which it suggested that the legislative body could implement stricter standards during the MDUFA reauthorization process. It seemed to be responding to efforts by industry to paint the current framework as a prohibitive burden, dismissing concerns about “onerous regulation.” 

The CU wants devices to go through an approval process similar to that which pharmaceuticals face. Device makers currently have to provide a “reasonable assurance” of safety, but the CU would like to see the standards changed so that a company must provide “substantial evidence” of safety. It wants the 510(k) program taken off the table when it comes to implantables or life-sustaining devices, arguing that such devices should only go through the full premarket approval (PMA) process, and wants recalled devices to no longer be allowed to be used as predicates for the approval of other devices.

The group also listed some steps that Congress could take to improve FDA’s regulation of devices postmarket, including requiring the implementation of a unique identifier system, funding programs like MedWatch, MAUDE, and the Sentinel initiative, and supporting the agency’s efforts to effectively manage recalls and postmarket studies. Finally, the CU wants Congress to “retain current conflict-of-interest standards for federal advisory committees.”

As the CU was taking this step, members of the bipartisan, bicameral Congressional medtech caucus sent their own letter to FDA commissioner Margaret Hamburg, asking her to preserve the industry and protect innovation by making changes to the agency’s approval process. The legislators cautioned that “unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”

The caucus members write that they “share [FDA’s] commitment to ensuring safe and effective medical devices are available to patients,” but “are very concerned about recent declines in FDA performance,” including ”increased review times, inconsistent expectations, and poor communication.”

They urge Hamburg to “recognize and correct the disparity between ‘FDA time’ and real time when tracking device approvals,” consider “benefits of harmonization with international testing standards,” address “the unintended consequences of advisory panel conflict-of-interest rules,” and create “a transparent tracking and review system for applications and clearness decisions.”