The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases

Authors

Puja Shah, McGovern Medical School
Oscar Olavarria, McGovern Medical School
Naila Dhanani, McGovern Medical SchoolFollow
Hailie Ciomperlik, McGovern Medical School
Cassandra Mohr, McGovern Medical School
Karla Bernardi, McGovern Medical School
Niharika Neela, McGovern Medical School
Rainna Coelho, HCA HealthcareFollow
Zuhair Ali, HCA HealthcareFollow
Ajita Prabhu, Cleveland Clinic
Mike K. Liang, HCA HealthcareFollow

Division

Gulf Coast

Hospital

HCA Houston Healthcare Kingwood

Document Type

Manuscript

Publication Date

9-25-2022

Keywords

510k process, FDA, conflict of interest, devices, recall, systematic review

Disciplines

Equipment and Supplies | Surgery | Surgical Procedures, Operative

Abstract

BACKGROUND: The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process which allows medical devices to be quickly introduced into the market. FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market, however as a result may be limited in its ability to establish the safety of these devices.

METHODS: The FDA 510(k) online archives were searched for devices cleared from 2013-2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications regarding the devices. Primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices.

RESULTS: A total of 6152 devices were cleared through the 510(k) process from 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%).

CONCLUSION AND RELEVANCE: There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced with potentially costly, non-beneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

Publisher or Conference

The American Journal of Medicine

Recommended Citation

Shah P, Olavarria O, Dhanani N, et al. The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases. Am J Med. 2023;136(2):172-178.e14. doi:10.1016/j.amjmed.2022.09.006