FDA’s Plan to Significantly Change the 510(k) Process

The Food and Drug Administration (FDA) is taking steps to significantly alter its process for clearing most medical devices for marketing in the United States. As part of the change, the agency intends to reduce the emphasis it has previously placed on utilizing comparisons with older medical devices and products.

The FDA’s dependence on these comparisons has been deemed flawed by many as an effective means of determining the adequacy and trustworthiness of medical devices to be sent into the market. This flaw, it is argued, has resulted in the distribution of defective medical devices, such as faulty metal hip implants and bloodstream filters. The FDA has relied on these comparisons, referred to as “substantial equivalence” instead of on comprehensive studies of the new medical products themselves.

The FDA modernization plan for evaluating device safety

On November 26, Scott Gottlieb, FDA Commissioner and Jeff Shuren, Device Center Director, published a statement outlining a plan for modernization that would overhaul the 510(k) premarket product evaluation program in order to substantially enhance medical device safely. As it stands now, the 510(k) pathway relies on comparisons performed between a potential medical devices and current legally marketed predicate devices. This process is responsible for the clearing of most medical devices on the market today.

Those opposed to this process have focused on its low standards that have allegedly led to serious patient safety issues. FDA officials report that almost 1 out of 5 current 510(k)s utilize a predicate that is more than a decade old. As a result, the concern exists that devices coming onto the market through this process may not be improving over time.

Currently the FDA uses the 510(k) pathway to clear to market about 8 in 10 medical devices. Most of the time this process does not include comparisons with a placebo or active treatment control group.

The new, revamped protocol the FDA plans to introduce in the early portion of 2019 will be called the Safety and Performance Based Pathway. This new pathway will utilize objective performance and safety criteria for the evaluation of particular types of devices onto the U.S. market.

Use of more modern predicate devices

The FDA intends to rely more heavily on modern predicate devices by potentially phasing out older predicates, specifically those more than a decade old. These older predicates will become unavailable for use in substantial equivalents determinations. The overhaul of the current 510(k) program may eventually require action from the U.S. Congress.

The FDA may call out older predicate devices in order to encourage voluntary application of newer predicates. The purpose of this phasing out process is to promote the implementation of more modern predicates and encourage sponsors to present devices that possess the most recent functional and safety improvements.

The statement issued by the FDA makes clear that its intention is not to remove products that were compared with older predicates from the market or announce they are unsafe. The goal, they state, is to promote the use of more modern predicates that provide “patients and their doctors a choice among older and newer versions of the type of device” and also foster competition for the design and manufacture of devices having technological features that improve device performance and safety.

If you have sustained an injury from a faulty medical device, the Los Angeles product liability attorneys at Taylor & Ring are here to hold those responsible for your injuries to account under the law. We can fight to help you secure the compensation you are owed for your losses. To arrange a free, initial consultation, call our legal team today at 310.776.6390 or fill out our contact form.