Since 1976, the U.S. Food and Drug Administration (FDA) has allowed manufacturers to apply for an accelerated pathway to bringing their devices to the market. It’s called the 501(k) Premarket Notification.
In short, if a new device gets proved safe and effective to a device that’s already available, the new device can get cleared because it’s considered substantially similar to the older one.
The FDA also allows for the first-cleared device (also known as the predicate) to be another product that got cleared through the 501(k) process. Data from a source outside of the FDA about average 501(k) clearance times found that in 2016, the timeframe was 177 days and that 19 percent of devices received clearance in less than three months.
However, a recent FDA announcement indicates the organization intends to “modernize” the device approval process.
1. Time to Make the Approvals Process More Applicable
The FDA clarified its decision by pointing out that although new technologies represent a substantial potential for the people who need medical devices, it is no longer sufficient to give the go-ahead for those high-tech items using decades-old standards.
So, the 501(k) pathway needs to be updated to either account for advances in technology or meet criteria for safety and performance that’s more current than the 1970s. The FDA noted that the 501(k) process recognizes that medical devices exist across a “continuum of complexity,” and believes that the 501(k) process should reflect that reality.
Additionally, the organization pointed out that almost 20 percent of new devices cleared received that approval based on a predicate device more than a decade old. They further mentioned that although the age of the previous device does not make the new one unsafe, it may not accommodate the benefits and risks of more modern technologies. Also, the outdated process may limit device improvements.
2. Substantial Similarity and New Technology
Determining substantial similarity generally involves both a new and currently available device that have the same intended use. It does not matter if the new device features technology that’s nothing like what the older product has — as long as such technology does not interfere with safety or effectiveness.
Many of today’s devices are tremendously dependent on digital technology, and manufacturers look for ways to make the devices incredibly powerful but streamlined. The products often generate substantial amounts of heat, requiring methods like heat-pipe technology to transfer the heat for dissipation purposes. Some older products also have cooling devices, but the technology used now represents notable progress compared to the earlier components that kept things at safe temperatures. Basing approvals on old technology ignores the enhancements in newer products.
3. No Intention of Removing Older Devices From the Market
The FDA has not said how it will make the 501(k) pathway more up to date, though there is a proposal that predicate devices should not be older than ten years if used to show that a newer device has the all-important substantial similarity.
The organization considered publishing a list of devices online that got approved based on predicate devices older than a decade. Then, patients and their physicians could better weigh the pros and cons of older devices versus newer ones.
The FDA does not want to take those older devices off the market, though. The aim of listing them centers upon informing the public, especially since the organization insists the older gadgets are not dangerous. Public feedback will guide whether or not the FDA moves forward with creating that device list.
The organization also discussed how it might be necessary to go to Congress to make changes regarding the 501(k) process, such as basing approvals on newer predicate devices.
4. A Timely and Alarming Report
The FDA’s published press release about its desire to bring the 501(k) process into modern times interestingly came only days after an investigative report compiled by more than 250 journalists in three dozen countries. Under the leadership of the International Consortium of Investigative Journalists, the group spent a year assessing the global damage caused by medical devices.
Doing that required analyzing more than eight million patient records related to medical devices. The team mostly looked at records from 2008 through 2017, although some of the information was older than that, and another portion of it related to the first half of 2018.
In all, the group determined medical devices caused more than 1.7 million injuries and almost 87,000 deaths. The report’s conclusions were even more powerful considering that the data came from the FDA’s Manufacturer and User Facility Device Experience (MAUDE).
5. The FDA’s Recent Change to Adverse Events Reports
The totals mentioned above are likely even higher, considering they don’t include unreported events. And, thanks to a rule change the FDA made earlier in 2018, it may soon be even more difficult to determine how risky it is for patients to use devices based on reports from other individuals.
The reports about most categories of devices can now come from manufacturers as quarterly summaries rather than detailed, unique accounts of patient problems. Lobbying groups working for medical product manufacturers probably prompted that development.
An NBC News analysis found that since the start of Trump’s presidency, ten companies spent a combined total of more than $36.5 million to influence medical industry regulations.
6. Much Uncertainty About the FDA’s Future Plans
Although the FDA’s focus on making the 501(k) pathway more relevant to today’s industry and technologies sounds promising, it’s too early to tell how things might end up.
Medical device manufacturers don’t want rules that could make it more challenging to get product approvals, because approved products translate into profits. And, if the FDA makes a transition to only allow predicate devices no older than a decade when comparing new items devices through the 501(k) process, companies behind them could encounter undesirable obstacles.
So, pushback and lobbying efforts could cloud the FDA’s goals, even as they endeavor to make much-needed improvements in device safety and patient outcomes.
Kayla Matthews is a contributing writer for HIT Consultant whose work has appeared on VentureBeat, The Week, Contagion Live and BioMed Central.
