Predicate Data Availability in the Ventilator 510(K) Network

Abstract

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.