4 Reasons Overhauling FDA 510(k) is a Great Move

    Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's reputations. In one of the most high-profile examples of medical device failure, tens of thousands of patients have reported debilitating injury after receiving a surgical mesh implant.

    It’s clear something must be done to address patient safety risks.

    Regulating medical devices using the same process and requirements as pharmaceuticals or biologics isn’t the right answer. Medical devices aren’t the same as prescription drugs. “If the FDA recalls pills, a patient can at least stop taking them immediately,” says Vanderbilt safety researcher Dr. Michael Matheny. However, “with implanted devices, patients are sort of stuck...and that's if surgeons can even safely remove them.”

    Fortunately, the FDA is taking action by changing the regulatory review process for medical device safety, known as Section 510(k) for Device Clearances.

    At Qualio, we firmly stand behind the FDA’s plan to overhaul 510(k) and create new a new framework of requirements for device safety before market approval. Read on to learn why these impending changes are good for everyone, from manufacturers to patients, and how to prepare your organization for a successful clearance.

    Why Overhauling FDA 510(k) is Good for the Medical Device Industry


    The 510(k) submission process allows medical device manufacturers to obtain market clearance if they were able to demonstrate a product had "substantial equivalence" to a "predicate device" approved for market.

    In the majority of cases, the 501(k) process was effective. In others, it had immense potential for failure, especially if the application is based on an unsafe device. If the "predicate device" an application was based on was never tested for patient safety there could be immense potential for failure.

    The FDA’s intent isn’t to scrap 510(k). Instead, manufacturers can expect the requirement to emerge with a new name and slightly more rigorous requirements for some types of device applications. "We believe firmly in the merits of the 510(k) process," says FDA Commissioner Scott Gottlieb. "But we also believe that the framework needs to be modernized."

    Here's what manufacturers can expect with the upcoming changes:

    • Difficulty gaining approval if your application is based on "substantial equivalence" to a device which was approved 10 years ago or more
    • More rigorous FDA oversight of product success and failures post-approval based on clinical data, billing data, and emerging research
    • The 510(k) is likely to be renamed the "Safety and Performance Pathway."

    These updates to 510(k) are an adequate response to the industry's reputation damage, the flaws in the concept of "substantial equivalence" and other current issues. Here's why they are a positive move for all stakeholders involved.

    Related Reading: How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps

    1. Recent Problems Have Raised a Negative Profile of the Industry

    Surgical mesh. Hip replacements. Saline breast implants. The media is talking about medical devices, but unfortunately, they’re focused on device failures. Negative press coverage has the potential to hurt device manufacturers and patients. Every device failure which hits the news can overshadow the remarkable innovation going on in the industry, such as 3D printing, smart monitoring, and embedded technologies.

    While FDA data confirms "the vast majority of patients implanted with medical devices have no adverse reactions," the small percentage of patients who experience device failures can overshadow success stories. People who could benefit significantly from a safe medical device may be hesitant to use it due to reading about the bad apples. Action is needed before patient safety, and the industry's reputation, experience permanent damage.

    2. "Substantial Equivalence" is a Good Idea that Needs to be Tweaked

    To be clear, no one is claiming the 510(k) process is a failure. Not every medical device requires human or animal testing to be safely brought to market, and the idea of "substantial equivalence" is frequently effective. However, the concept of substantial equivalence doesn't always work, which is why the 501(k) requires some updates.

    The FDA reports the average size of an application for medical device approval has doubled in length in recent years to a total of 1,185 pages. The majority of manufacturers approach the market approval process with rigorous data and evidence, instead of relying on substantial evidence like a crutch to gloss over safety issues.

    3. A Proactive Approach is Fitting

    The FDA plans to take a proactive approach to patient safety by moving ahead of patient complaints and watching how devices perform in the real world as soon as they are cleared for market. This is smart given the rapid speed of innovation in the medical device field and continually improving knowledge in related areas, such as material science. Also, simulations and testing data cannot always predict how medical devices will benefit or harm patients once in use. Clinical data is the most effective path to understand medical device safety.

    “We have a number of tools in place to monitor a device’s benefit-risk profile as it is used in a real-world setting,” states a recent FDA press release on device safety. The agency plans to double-down on implementing and improving the National Evaluation System for health Technology (NEST). The NEST will aggregate a huge amount of data from “clinical registries, electronic health records, and medical billing claims” in real time to help the regulatory body understand device safety and performance. This proactive approach will help the FDA identify performance failures before they have a widespread impact.

    Related Reading: The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

    4. Changing the Name to "Safety and Performance-Based Pathway" Will Help

    While many in the industry will continue to use 510(k) for brevity, changing the name to "safety and performance-based pathway" will keep the industry focused on the primary goal. Medical device manufacturers do business to improve patient outcomes through innovation. The new name also addresses the FDA’s intent to introduce three distinct categories of approval application, a traditional, special, or abbreviated 510(k).

    Will your organization qualify for an abbreviated application process which uses substantial evidence? You may be able to use a fast-track to clearance if:

    • Your device does not raise questions of effectiveness or safety
    • Your device meets all FDA-identified performance criteria
    • Your performance criteria align with at least one legally marketed device of the same type

    How to Prepare for an FDA 510(k) Overhaul

    It doesn't make sense to apply pharmaceutical safety testing process and requirements to every medical device, from tongue depressors to 3D-printed implants. In some cases, relying on the safety of legally marketed devices is sufficient evidence. In other instances, rigorous simulation and clinical trials are necessary.

    Fortunately, the FDA is taking a proactive, data-driven approach which puts patient safety first. The new 501(k) process will consider the needs of medical device manufacturers and the nuances of the industry. The overhaul to the 510(k) process is unlikely to impact organizations who approach the approval process with strong safety data and evidence.

    Like the FDA, you should take a proactive approach. Prioritize a quality-driven culture over a compliance-driven culture in your medical device company. Start by downloading our eBook: 7 Things You Can Do Now to Improve Quality in Medical Device Product Development