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Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
Sanket S Dhruva1, Lisa A Bero, Rita F Redberg
1Division of Cardiology, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143-0124, USA.
JAMA
|December 31, 2009
Summary
US Food and Drug Administration (FDA) approval for cardiovascular devices often relies on weak evidence. Many studies lack randomization, blinding, and adequate controls, potentially introducing bias.
Area of Science:
- Cardiovascular medicine
- Medical device regulation
- Evidence-based medicine
Background:
- Medical devices significantly impact patient outcomes.
- The US Food and Drug Administration (FDA) approves medical devices.
- A systematic review of evidence for FDA device approval is lacking.
Purpose of the Study:
- To examine the premarket approval (PMA) process for cardiovascular devices.
- To characterize the type and strength of evidence used in cardiovascular device PMA.
Main Methods:
- Systematic review of 78 PMA summaries for high-risk cardiovascular devices (2000-2007).
- Analysis of 123 supporting studies' methodological characteristics and primary endpoints.
- Evaluation of evidence strength, bias, and confounding minimization.
Main Results:
- Only 27% of studies were randomized; 14% were blinded.
- 65% of PMAs were based on a single study.
- 52% of endpoints used controls, but 31% were retrospective; 88% of endpoints were surrogate measures.
Conclusions:
- Premarket approval for cardiovascular devices frequently uses low-strength evidence.
- Studies supporting device approval may be susceptible to bias.
- The FDA's review process for cardiovascular devices may require stronger evidence.
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