Safety Evidence Lacking For 510(k) Devices, Study Finds
By Jof Enriquez,
Follow me on Twitter @jofenriq
A study published in JAMA Internal Medicine claims that the U.S. Food and Drug Administration (FDA) has failed to adhere to a law requiring the public disclosure of safety information on new medical devices cleared by the agency.
Researchers from the National Center for Health Research think tank conducted a review of scientific evidence backing approved moderate- to high-risk medical devices and found out that “42 of 50 selected medical devices cleared by the FDA over five years lacked such data, despite a 1990 law calling for sufficient detail to justify their FDA clearance,” according to The Wall Street Journal (WSJ).
“For implants cleared between 2008 and 2012 ... scientific evidence of the substantial equivalence, safety or effectiveness of medical devices was not publicly available in accordance with the legal requirements,” the authors wrote in the study summary. “To protect the public health and allow for independent judgment of the quality of the scientific evidence that supports the marketing of medical devices, the FDA should enforce the law.”
Moreover, the study revealed that in the past five years, only 31 of 1,105 “predicates” had scientific data to support their claims, according to The Philadelphia Inquirer. A predicate is a device cleared because it was deemed equivalent to one already on the market.
The JAMA study included products such as joint replacement devices, surgical mesh devices, artificial teeth supports, and patches to repair holes in the heart. The WSJ’s Tom Burton said in the report that newer devices have functions and features that, over time, get less connected or less identical to their predicate devices. These new iterations may not be necessarily safe just because their predicates were deemed to be so.
“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them,” said Diana Zuckerman, the study’s lead author and president of the National Center for Health Research in Washington, D.C., according to Reuters.
Critics and patients claim that fast-tracking devices such as metal-on-metal implants and transvaginal mesh devices under the 510(k) pathway had ultimately brought harm to patients, according to Drug Watch. The FDA had released new guidelines in the wake of backlash and lawsuits in order to tighten and clarify the program, but manufacturers can still bypass the full range of testing prior to approval.
In a response to the JAMA study, the FDA acknowledged that the public has access to limited information because manufacturers are only required to disclose a summary, in accordance with the Safe Medical Devices Act of 1990.
“However, the FDA reviews a significant amount of data – far more than what is publicly available – to determine whether or not to clear an implantable device under a 510(k),” the FDA said in a statement to Reuters. “This approach has served the American public well by balancing the need for robust evidence to assure safety while expeditiously bringing new technologies to the patients who need them.”
The Institute of Medicine in 2011 called for a revamp of the 510(k) clearance process, noted the WSJ. The organization said then that "reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective."
Michael Drues, Ph.D., president, Vascular Sciences, disagreed in an article for Med Device Online. He wrote that the controversial “510(k), and more specifically the substantial equivalence regulatory logic, is a valid path to bring medical devices onto the market when used properly. But like any tool, it can be misused. The key to making this or any regulation work is not to focus on the regulation, but rather the negotiation between the manufacturer and the FDA — that is what will ultimately determine how long a submission will take and whether it will be successful.”