Date of Award
Master of Public Health (MPH)
School of Public Health
Joseph S. Ross
Background: The US Food and Drug Administration (FDA) is in charge of regulating medical devices and one key power the FDA has to ensure safety and effectiveness of these devices is risk reclassification. One example of this regulatory power is the 515 Program Initiative, where the FDA was tasked with reclassifying preamendment devices that had never undergone initial rigorous review before entering the market.
Objective: The objective of this thesis project is to characterize the device types reassessed under this program and determine what characteristics the FDA heavily considers when making a risk classification determination.
Methodology: Data was collected on all 23 device types reviewed through this initiative on a variety of characteristics: therapeutic area, implantable, life-sustaining, reclassification mechanism, prior 510(k)s, devices out after reclassification, advisory committee decisions, recalls, and public comments. Additionally, Fisher exact tests were conducted to assess whether these characteristics were associated with final risk classification decisions.
Results: Of the 23 classification rules and orders, 15 called for downclassifications from Class III to Class II or Class I device types and 8 called for devices to remain Class III. Most device types characteristics were not significantly associated with the downclassification decision, except for advisory committee decisions (P = 0.000) and reclassification mechanism (P = 0.000).
Conclusion: The FDA should consider these key regulatory processes when making reclassification decisions. These findings suggest that the FDA prioritizes certain key players, such as experts within advisory committees, during their decision-making process and that regulatory burdens could both help and hinder the FDA’s mission to ensure safety and effectiveness.
Hu, Tiffany Ning, "Analysis Of Medical Device Reclassification: An Evaluation Of The 515 Program Initiative" (2020). Public Health Theses. 1948.