The Food and Drug Administration (FDA) is updating its medical device regulation process to better align with the rapid pace of technological advancement. The stated intention is to promote “modern patient care” by ensuring the safety and effectiveness of today’s medical devices while promoting technological innovation.
In November the FDA announced it was taking “transformative new steps to modernize” its application process known as the 510(k) pathway, through which the majority – more than 82 percent in 2017 – of new devices are cleared. Finalized guidance on the proposed changes is expected in the early part of this year.
The 510(k) process has come under fire in recent years due to adverse events such as bloodstream filters that fractured and defective metal hip implants, according to the Wall Street Journal. The Institute of Medicine, an affiliate of the National Academy of Sciences, asserted back in 2011 that the clearance process was not reliable and should be “scrapped” altogether.
The clearance process is intended for low-to-moderate-risk devices and differs from “approval,” the other FDA designation allowing devices to be sold. “Cleared” medical devices are those the FDA has determined are similar enough to existing medical devices on the market whose safety and efficacy has already been established. Existing medical devices used as a reference for clearance are called “predicate” devices. New devices which don’t closely resemble an existing medical device are required to go through the more “rigorous review” of the approval process.
Certainly, a lot has changed in terms of medical technology since Congress first established the 510(k) process back in 1976. Part of the Medical Device Amendments to the landmark 1938 Food, Drug and Cosmetics Act, the 510(k) legislation did not include time limits on the age of predicate devices – and this is the agency’s current concern.
In a joint Nov. 26 statement, FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Devices and Radiological Health Jeff Shuren said that the agency is considering placing a 10-year limit on predicates, according to MedCity News.
Gottlieb and Shuren explained that changes to the 510(k) process were needed to help the agency keep pace with the increasing complexity of medical technology innovations. While offering tremendous promise to patients, these advances have posed challenges to the existing safety and effectiveness evaluation framework.
“Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” Gottlieb and Shuren stated.
“We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates,” they stated.
While the agency is considering publicizing those devices that relied on older predicates during the clearance process, it said that it does not intend to pull these devices off the market or to give the impression that they’re unsafe.
Scott Whittaker, CEO of Advanced Medical Technology Association, an industry trade group, has objected to the 10-year limit as “arbitrary” and said that older predicates offer extensive safety data, CNBC reported.
Meanwhile, there are legal questions about the extent of the FDA’s power to make changes to the 1976 legislation.
“As a matter of law, I think there’s a significant issue as to whether FDA could go about implementing a program that declares certain products not to be predicate devices simply because they’re old,” attorney Jeffrey N. Gibbs told Law360. “Congress in the statute laid out the criteria for being a predicate device and age was not one of them.”