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Review
. 2010 Jul 13;7(7):e1000280.
doi: 10.1371/journal.pmed.1000280.

Left to their own devices: breakdowns in United States medical device premarket review

Jonas Zajac Hines  1 , Peter Lurie, Eunice Yu, Sidney Wolfe
Affiliations
Review

Left to their own devices: breakdowns in United States medical device premarket review

Jonas Zajac Hines et al. PLoS Med. .

Abstract

Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.

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Conflict of interest statement

PL is now with the U.S. Food and Drug Administration, where he is Senior Advisor in the Office of the Commissioner. He began at the FDA in December 2009; the manuscript was submitted before he began employment at the FDA. The opinions expressed here are his and do not represent the official position of the U.S. FDA or the U.S. government.

Figures

Figure 1
Figure 1. Schematic representation of medical device premarket review mechanisms.
Note: Issues listed in circles. Issue 8 does not appear in Figure 1. SE, substantially equivalent. * The 1997 FDAMA exempted most class I devices and a small number of class II devices from 510(k) requirements. € If determined to be not substantially equivalent, the sponsor may submit a PMA application. Alternatively, a sponsor may request evaluation under the de novo pathway (see text). Δ Post-decision scheme not illustrated.
Figure 2
Figure 2. Class III 510(k) device types not fully reviewed by the FDA, 1976–2009.
Note: if a device was later determined to have more than one indication, the review was considered complete only after all indications had been reviewed.
See this image and copyright information in PMC

References

    1. Washington, DC: Government Printing Office.; 2006. Definition of a medical device. Federal food, drug, and cosmetic act. Publication No. 21 USC § 321(h) (2006 ed.)
    1. Ramsey SD, Luce BR, Deyo R, Franklin G. The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care. 1998;4 Spec No:SP188–199. - PubMed
    1. Roland G, Donahoe G. 2009. Estimates of medical device spending in the United States, 1989-2006. Available: http://www.advamed.org/NR/rdonlyres/6ADAAA5B-BA37-469E-817B-3D61DEC4E7C8.... Accessed January 17, 2010.
    1. Centers for Disease Control and Prevention. Elevated risk of pelvic inflammatory disease among women using the Dalkon Shield. Morb Mortal Wkly Rep. 1983;32:221–222. - PubMed
    1. U.S. House of Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. Washington, DC: Government Printing Office. Comm. Print 1990; 1990. The Bjork-Shiley heart valve: earn as you learn; Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation: a staff report.

MeSH terms