FDA’s Revamped Approach to Device Safety Will Significantly Change the 510(k) Process

The Food and Drug Administration (FDA) has decided to significantly change the way it clears the majority of medical devices for marketing in the U.S. The agency plans to place much less emphasis on allowing comparisons with older medical products.

The federal agency’s reliance on these comparisons has been considered by many as a flawed method for determining the adequacy of medical devices to be sold in the marketplace. It is argued that this flaw has led to the distribution of faulty devices, such as defective bloodstream filters and metal hip implants. Rather than relying on complete studies of these products, the FDA has followed the standard referred to as “substantial equivalence” that involves comparisons with already cleared devices of considerable age.

The FDA modernization plan for evaluating device safety

On November 26, 2018, Commissioner of the FDA, Scott Gottlieb and Device Center Director Jeff Shuren published a statement detailing a modernization plan that intends to revamp the 510(k) premarket evaluation program to significantly improve medical device safety. Currently, the 510(k) pathway depends on a prospective medical device undergoing a comparison with a legally marketed predicate device – this is a similar device already deemed legally marketable. Most medical devices are cleared for the market through this 510(k) process.

Critics have pointed to the low standards required by this current process and alleged patient safety issues that have resulted. According to FDA officials, “Data show that nearly 20 percent of current 510(k)s are clearly based on a predicate that’s more than 10 years old.” They further state that as a result, “some devices may not be continually improving.”

The FDA currently uses the 510(k) process to clear approximately 82 percent of medical devices. This generally does not involve the application of gold standard studies in which the product undergoes a comparison with an active treatment control group or a placebo.

The new guidance planned by the FDA for introduction in early 2019 will be called the Safety and Performance Based Pathway. It will allow particular well-understood types of devices to be evaluated based on objective safety and performance criteria for clearance onto the U.S. market.

Use of more modern predicate devices

As a concerns the current 510(k) pathway, the FDA intends to shift the dependence on more modern predicate devices through the potential sun-setting of older predicates – those more than 10 years old – and make them unavailable for substantial equivalence determinations. Congressional input may be required at some point to assist with this fundamental revamping of the current 510(k) program.

Meanwhile, the FDA, in its effort to encourage voluntary application of newer predicate devices, has expressed its possible intention of calling out predicate devices that are greater than 10 years old. The purpose of phasing out older predicates is to foster the implementation of more modern predicates and encourage sponsors to introduce devices with the most recent improvements.

The FDA’s statement goes on to clarify that the agency’s intention is not to eliminate products with older predicates from market or to claim they are unsafe. The goal of the agency is to simply spur the use of more modern predicates by product developers that give “patients and their doctors a choice among older and newer versions of a type of device” as well as promote competition for the development of devices with technological features that enhance safety device and performance.

If you have suffered an injury due to a medical device, our Chicago product liability and medical malpractice attorneys at Gainsberg Injury and Accident Lawyers can fight on your behalf to hold liable those responsible for your injuries. We can vigorously advocate on your behalf for the compensation you deserve. To set up a free case evaluation, call us today at 312-600-9585 or complete our contact form.