Journal of Science Policy & Governance
​Volume 22, Issue 01 | March 6, 2023

Policy Analysis: Predicate Data Availability in the Ventilator 510(K) Network

C. Abby Bratton, Mercy Chado, Austin Davis, Julia Vaillancourt, Sandra Rothenberg, Ezekiel Leo
  1. Rochester Institute of Technology, Department of Public Policy, Rochester, New York
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Corresponding author: [email protected]
Keywords: predicate networks; data availability; data transparency; medical ventilators; premarket notification; 510(k) pathway
https://doi.org/10.38126/JSPG220104 ​

Executive Summary

Past research has substantiated concerns over transparency in medical device clearance and approval by the Food and Drug Administration (FDA), including a lack of publicly available data. Transparency in this process is necessary for patients and researchers to understand why products are granted or denied clearance for public use, allowing them to make informed decisions ranging from the innovation of future products to personal healthcare judgements. This insight is important for the premarket notification process known as the “510(k) pathway,” the regulatory process through which most medical devices are cleared for commercial distribution in the United States. This process relies on demonstrations that a new product is substantially equivalent to an existing product on the market, referred to as a predicate device. 

One metric of transparency of the 510(k) pathway is the public availability of 510(k) submission summaries and the data they contain on substantially equivalent predicate devices. We analyze predicate data availability for medical ventilation devices cleared through the 510(k) pathway across a range of time intervals and product codes using one-way analysis of variance testing and Tukey’s method of multiple comparison. Out of all cleared medical ventilation devices whose submissions were received from January 1990 through October 2020, 65.64% list publicly available predicate information, primarily through summary documents in the FDA 510(k) Premarket Notification database. There is a statistically significant increase in the percentage of device submissions with available predicate data over time, with predicate data available for 93.17% of all devices submitted in the fifteen-year-period between the beginning of 2005 and the end of 2019.

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Background header image courtesy of Regdesk
C. Abby Bratton is a PhD student in Communication and Science Studies at the University of California San Diego. Her research interests include the communication of emergent biotechnologies and the accessibility of bioethical discourse. She received a B.S. in Biomedical Engineering with a Creative Writing minor and an M.S. in Science, Technology, and Public Policy from the Rochester Institute of Technology in 2022. 

Mercy Chado is a research associate in the therapeutics lab of the Cystic Fibrosis Foundation. She works in genomics and bioinformatics where she identifies promising drugs or treatments for rare forms of cystic fibrosis using next-generation sequencing. She received a B.S. in Biomedical Engineering and an M.S. in Science, Technology, and Public Policy from Rochester Institute of Technology in 2022. 

Austin Davis is a BS candidate in the Biomedical Engineering program and a MS candidate in the Science, Technology, and Public Policy program at Rochester Institute of Technology and is expected to graduate May 2023. He studied the transparency of information and the potential effect of predicate creep within the FDA’s 510(k) pathway by exploring the ventilator device space. He plans on pursuing a Biomedical Engineering career after graduating. 

Julia Vaillancourt received a MS in Science, Technology, and Public Policy and a BS in Biomedical Engineering in 2022 from Rochester Institute of Technology. Julia studied medical device recall data and ancestry networks to assess the FDA's 510(k) process. Julia works at Hologic, Inc. where she aids in the international registration of medical devices. 

Sandra Rothenberg is the Chair of Public Policy, Professor of Management at the Saunders College of Business in the Department of Management, and Director of the Institute for Business, Government and Society at RIT. She teaches in the areas of Public Policy, Organizational Behavior, Business and Society, and Sustainable Management. Her research focuses on business ethics, sustainable business, corporate social responsibility, and business and public policy. 
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Ezekiel Leo is an assistant professor at Rochester Institute of Technology in the management department. His research examines issues at the intersection of technology and organization, such as modularity in product and organization, IT outsourcing, and medical device innovation. His works have been published in Journal of Strategic Information Systems, Journal of Product Innovation Management, Multinational Business Review, and other academic journals. He received a B.A. degree in computer science and economics at University of California, Berkeley, and Ph.D. degree in strategic management and entrepreneurship at University of Illinois, Urbana-Champaign.

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