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FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program

Since May 28, 1976, the United States (U.S.) Food & Drug Administration (FDA) has had an alternative in place to the extremely burdensome Investigational Device Exemption (IDE) and Pre-Market Approval (PMA) processes to get new products onto the market, and that alternative is called the 510(k) process.

By definition, “510(k) merely refers to the relevant section of the U.S. Food, Drug and Cosmetic Act (FD&C) that allows companies with a new device to compare their product to an already marketed product (a predicate) that works in an equivalent fashion and has the same intended use” (FDA). A company seeking market clearance of their new product under the 510(k) process must prove that the new device is at least as safe and effective as the predicate device. For this reason, it is becoming more common that this proof be provided via the conduct of rigorous FDA-approved clinical studies.”

Further, when global device makers select a predicate device for approval purposes, in some cases, that particular device may have been on the market for decades—and perhaps no longer used or marketed. The way in which the original law was written by the FDA, Sponsors may compare a new device to any predicate, regardless of how long it has been on the market.

However, since 1976, the FDA has eliminated the use of 1,758 devices as predicates in the 510(k) process due to device safety concerns. Of these, 1,477 (84 percent) have been eliminated since 2012, a 30-fold increase. It is expected that this trend will continue in the near-term as older products become obsolete based on new technology and/or the evolution of health care practices.

FDA’s Shifting Paradigm

Over the past several years, the FDA’s Center for Devices and Radiological Health (CDRH) has worked actively to eliminate the use of 510(k)-cleared predicates that were subject to safety concerns and treated as high-risk technologies. Many of these devices were “up-classified” by the CDRH—simply put, the devices were judged to be at a high enough risk that they were reassigned to Class III, which then required the PMA approval route, the most stringent process available today in the U.S. for medical devices. “Up-classification” examples of previously cleared 510(k)s include vaginal mesh for the treatment of pelvic organ prolapse, automated external defibrillators and metal-on-metal hip implants. These devices have been deemed to be high-risk and can no longer be brought to market via the 510(k) pathway.

Recently, the FDA has issued statements indicating that the agency would undertake “modernization” activities related to the 510(k) process. One proposed action is to make devices approved on predicates over ten (10) years old public on the CDRH website. (It should be noted that the FDA does not specifically claim older devices as unsafe, or even inappropriate, but simply encourages use of newer devices to boost innovation.)

Additionally, to address concerns surrounding older predicates and rapid technological innovations, the FDA stated that in early 2019 they intend “to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.”

In keeping with this paradigm, the FDA intends to allow for a new alternative “Safety and Performance Based Pathway” for low-moderate risk devices where a company would only have to demonstrate that their device meets performance-based criteria that the FDA has set to bring their product to market. Additionally, as part of this modernization process, the FDA plans to release new regulations related to procedures and requirements for DeNovo requests. It is also expected that the FDA will propose more streamlined processes for implementation of special controls, which will allow the agency to address safety concerns more rapidly.

All of the above changes are a part of the FDA’s broader review of the 510(k) market clearance pathway, shifts that clearly demonstrate their dedication to encouraging medical device technology innovation.

What Does this Mean for U.S. Medical Device Manufacturers?

Moving forward, Sponsors may want to rethink their scientific and regulatory strategies in their efforts to obtain FDA clearance of their medical devices. It may be wise to see if it might be acceptable to utilize the new “alternative” pathway (when introduced by the FDA early next year) to demonstrate substantial equivalence.

If manufacturers compare their device under review to a previously cleared predicate, in many cases, it would be best to liken the device to a predicate that received clearance within the prior ten (10) years. In addition, the 510(k) DeNovo process provides another pathway for those sponsors who cannot find an appropriate predicate. Whatever approach you choose it is important to discuss your proposed pathway and/or predicate with FDA before beginning any studies to support 510(k) clearance.

To read the full FDA announcement regarding proposed changes to the 510(k) program, issued on November 26 by Commissioner Scott Gottlieb, MD and Director of CDRH Jeff Shuren, please click here.

How Can NAMSA Help?

Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner at the right time can be invaluable in achieving accelerated timelines, reimbursement requirements and market success.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (read our most recent case study here).

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.

Richard Kotz

Richard Kotz, Senior Product Development Strategist

Richard Kotz currently works as a Senior Product Development Strategist at NAMSA, the world’s only Medical Research Organization (MRO). He retired from the U.S. Food and Drug Administration (FDA) in 2015 after 25 years as a statistical reviewer and manager in the Center for Devices and Radiological Health, Division of Biostatistics. He led a team of statisticians that reviewed hundreds of clinical trial protocols for Ob-Gyn, urology, gastroenterology, respiratory, diabetes, renal, oncology, anesthesiology, infection control and general surgery devices. He had leadership roles in several statistical organizations, including serving as president of the FDA Statistical Association and chair of the Medical Device and Diagnostic Section of the American Statistical Association. He was awarded the FDA's prestigious Lifetime Achievement Award in 2016.