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. The FDA 510(k) process is designed to minimize the burden and expense
of bringing new devices to market; however, as a result, the FDA 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 to 2014.
One thousand devices were randomly selected. PubMed was searched for each device to
identify publications about the devices. The 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 in 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 to potentially costly, nonbeneficial, or harmful devices.
Devices, like prescription drugs, should undergo a more rigorous clearance process.
Keywords
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Article Info
Publication History
Published online: September 25, 2022
Publication stage
In Press Journal Pre-ProofFootnotes
Funding: The authors received no external funding support for this manuscript.
Conflicts of Interest: The authors have no conflict of interest to disclose.
Authorship: All authors had access to the data and a role in writing the manuscript.
Identification
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