Happy 50th Birthday to the FDA’s 510(k) program, you’re now old and easily exploited.
Picture a game of Jenga. Each turn, you try your best to line up a block with its foundation below. While each block, off by a millimeter, may seem harmless; errors accumulate. The tower grows level by level, but eventually, it collapses.
This game of Jenga is much like the way many medical devices around the world have been approved. Instead of robust clinical evidence reviews, regulatory bodies like the United States Food and Drug Administration (FDA) and entities across the European Union (EU) have historically asked manufacturers to simply demonstrate their new devices are “equivalent” to older approved “predicate” technologies. After repeated rounds of claiming equivalence, many devices today stray far from the predicates for which approval was first granted.
While the medical device market has grown substantially across both the U.S. and the EU, regulatory frameworks are evolving at different paces. As Europe takes steps to shore up safety, the U.S. has doubled down on this pro-innovation pathway. If this continues, the U.S. will become the largest medical device market and have the most relaxed regulatory regime – a perfect cash cow for any business.i Without any concrete efforts to shore up safety, this may result in Americans becoming the guinea pigs for medical devices across the world.
Safety lapses from equivalence-based approvals have been documented time and again. Release of metal particles from cobalt-on-cobalt joints caused poisoning.ii Transvaginal mesh implants resulted in scarring, infections, and repeated surgeries.iii
In each instance, manufacturers nudged the FDA to provide approval based on equivalence to previous devices, without sufficient safety evaluations for new components. The poisonous joints were deemed substantially equivalent to predicate models, skipping the need to provide clinical evidence, despite changes in material and joint hinge design.iv Vaginal mesh implants trace back through long predicate chains to a 1950s hernia treatment, one that had limited clinical evidence.v
The scale of the problem is massive. In 2018, the International Consortium of Investigative Journalists estimated that this broken process contributed to nearly two million injuries and over 80,000 deaths in the U.S. alone over a decade.vi
Facing these safety concerns, the EU took decisive action to reform its approval processes. The Medical Device Regulation (MDR),vii introduced in 2017, reclassified the risk level of devices and reduced instances where equivalence required little to no clinical evidence. The new regulatory framework also mandated stricter post-market surveillance and granted reviewing bodies more audit authority.
In contrast, the Institute of Medicine of the National Academies, the U.S.’s congressionally chartered scientific expert group, concluded in 2011 that demonstrating “substantial equivalence to any previously cleared device” through “the 510(k) process cannot be transformed into [an] evaluation of safety and effectiveness.”viii Despite the recommendation to repeal and replace the pathway, the U.S. instead kept its flawed 510(k) system with only incremental reforms.
As the global medical device landscape shifts, the FDA now sets the lowest evidentiary bar for approval. As a result of stricter EU regulations, one survey found that manufacturers are now prioritizing FDA approval over other markets.ix Some studies go as far as to reveal that manufacturers are planning to remove devices from the EU to avoid compliance with stricter regulatory regimes and, instead, focus on markets with lower regulatory burdens like the U.S.x
While some may celebrate the industry’s decision to focus on the U.S. market as an exemplification of American innovation, this is unsustainable for the current system.
On top of a projected increase in submissions, the current Administration’s moves to shrink the FDA have also reduced our ability to properly consider these submissions. The reorganization of Health and Human Services gutted 3500 jobs at the FDA since February 2025, directly impacting the office that manages device reviews and recalls.xi Despite a decrease in force, the FDA cleared 3,237 510(K) submissions in 2025, a ~5% increase compared to the prior year.xii Agency processing time commitments mean that FDA reviewers now must process 510(k) submissions in less time, increasing the probability of safety failures.
The FDA recently issued guidance to address key gaps in the 510(k) process.xiii These include suggestions to industry on how to select better predicate devices and when evidence may be necessary to determine equivalence. While these efforts are laudable, they rely on the industry to obey non-binding guidance. Especially as we enter a post-Chevron world where agency rules and decision-making are under scrutiny, failing to codify these recommendations in statute is risky. Simply put, these incremental reforms don’t go far enough to protect safety, especially given growing submission volumes and decreased staff.
The FDA is understaffed and operating within a regulatory regime that prioritizes manufacturer convenience over safety. For the agency to properly protect the safety of Americans, Congress must heed the Institute of Medicine’s still-relevant advice and adopt risk classification-based evidence standards with a bolstered market surveillance program, as seen in the EU.
It may look like the U.S. has won the race for medical device innovation today. But set against a broken safety system, the risk of continued failures is immense. Congress must act to shore up safety requirements before America becomes the medical device manufacturers’ testing sandbox.
[1] MedTech Europe. “Market – MedTech Europe – The European Medical Technology in Figures.” Accessed January 20, 2026. https://www.medtecheurope.org/datahub/market/.
[2] Turner, Terry, and Cassandra L. Sundblad. “DePuy Hip Implant Failures, Health Risks & Corporate Controversies.” Drugwatch, April 23, 2025. https://www.drugwatch.com/hip-replacement/depuy/.
[3] University of Arkansas for Medical Sciences. “Vaginal Mesh Complications.” Accessed January 20, 2026. https://uamshealth.com/condition/vaginal-mesh-complications/.
[4] Pierce | Skrabanek. “510(k) Loophole in Medical Device Cases.” July 3, 2014. https://www.pstriallaw.com/legal-news/510k-loophole-in-medical-device-cases.
[5] Heneghan, Carl J., Ben Goldacre, Igho Onakpoya, et al. “Trials of Transvaginal Mesh Devices for Pelvic Organ Prolapse: A Systematic Database Review of the US FDA Approval Process.” Surgery. BMJ Open 7, no. 12 (2017): e017125. https://doi.org/10.1136/bmjopen-2017-017125.
[6] International Consortium of Investigative Journalists. “Medical Devices Harm Patients Worldwide As Governments Fail On Safety.” November 25, 2018. https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/.
[7] European Medicines Agency. “Medical Devices.” November 28, 2018. https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices.
[8] Institute of Medicine. Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC, 2011. https://www.nationalacademies.org/read/13150/chapter/1.
[9]Johnson, Christian, Jennifer McCaney, Kwane Ulmer, et al. For Cutting-Edge Innovations, the US Pulls Ahead of the EU in Medtech Regulation. Boston Consulting Group, 2022. https://www.bcg.com/publications/2022/us-ahead-in-medtech-regulation.
[10] Kearney, Breda, and Olivia McDermott. “Challenges Faced by Manufacturers with Clinical Evaluation under the New European Medical Device Regulations.” Cogent Engineering 10, no. 2 (2023): 2261236. https://doi.org/10.1080/23311916.2023.2261236.
[11] Reuter, Elise. “‘Just Goodbyes and Crying’: CDRH Hit in HHS Mass Layoffs.” MedTech Dive, April 2, 2025. https://www.medtechdive.com/news/fda-cdrh-device-rif-cuts/744212/.
[12] U.S. Food and Drug Administration. “510(k) Premarket Notification.” Accessed January 20, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
[13] Levine, Gregory H., Joshua Oyster, and Michael J. Purcell. “A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to Modernize the 510(k) Notification Pathway.” Ropes & Gray. Accessed January 20, 2026. https://www.ropesgray.com/en/insights/alerts/2023/09/a-step-forward-fda-issues-three-draft-guidance-documents-as-part-of-efforts-to-modernize.