Medical device regulation: time to improve performance
- PMID: 22859912
- PMCID: PMC3409121
- DOI: 10.1371/journal.pmed.1001277
Medical device regulation: time to improve performance
Abstract
Sanket Dhruva and Rita Redberg comment on a research study evaluating the evidence regarding the performance of device regulatory systems. They argue that adequate funding and increased transparency are vital to future reform.
Conflict of interest statement
RFR is a member of the FDA Circulatory System Devices Panel and the California Technology Assessment Forum. SSD has declared that no competing interests exist.
Comment on
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How does medical device regulation perform in the United States and the European union? A systematic review.PLoS Med. 2012;9(7):e1001276. doi: 10.1371/journal.pmed.1001276. Epub 2012 Jul 31. PLoS Med. 2012. PMID: 22912563 Free PMC article.
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