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

Hines JZ, Lurie P, Yu E, Wolfe S - PLoS Med. (2010)

View Article: PubMed Central - PubMed

Affiliation: Health Research Group at Public Citizen, Washington, DC, United States of America. jonas.hines@ucsf.edu

ABSTRACT

The number and complexity of medical devices have increased over the past several decades. A series of recent safety issues have raised public awareness about shortcomings in the Food and Drug Administration's (FDA) regulation of medical devices.

We provide a background on medical device premarket review and identify eight addressable weaknesses in the process.

These include a lower approval standard than their drug counterparts, excessive reliance upon a fast-track process, and failure to conduct Congressionally mandated device classifcations.

Paradigmatic cases drawn from recent Food and Drug Administration regulatory proceedings illustrate each weakness.

Show MeSH
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.
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC2903853&req=5

pmed-1000280-g002: 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.

Mentions: We tracked the 135 class III preamendments device types identified by the FDA in 1994 to establish their current regulatory status (Figure 2) [48]. The FDA had issued regulations for only 5% (seven types) of these devices at the time of the 1990 SMDA. By the 1996 deadline, it had complied with the statutory mandate for only 38% of class III preamendments devices. At present, the FDA still has not completed regulatory proceedings for 22 of the original 135 class III preamendments device types (16%), allowing them to continue to serve as predicate devices under the 510(k) process. According to a recent United States Government Accountability Office report [11], two-thirds of all class III preamendments devices cleared from FY2003–2007 were implanted, life-sustaining, or posed a significant risk. Responding to this report, the FDA recently initiated the process of determining whether a PMA would be required for most of the remaining devices [50].


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

Hines JZ, Lurie P, Yu E, Wolfe S - PLoS Med. (2010)

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.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2903853&req=5

pmed-1000280-g002: 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.
Mentions: We tracked the 135 class III preamendments device types identified by the FDA in 1994 to establish their current regulatory status (Figure 2) [48]. The FDA had issued regulations for only 5% (seven types) of these devices at the time of the 1990 SMDA. By the 1996 deadline, it had complied with the statutory mandate for only 38% of class III preamendments devices. At present, the FDA still has not completed regulatory proceedings for 22 of the original 135 class III preamendments device types (16%), allowing them to continue to serve as predicate devices under the 510(k) process. According to a recent United States Government Accountability Office report [11], two-thirds of all class III preamendments devices cleared from FY2003–2007 were implanted, life-sustaining, or posed a significant risk. Responding to this report, the FDA recently initiated the process of determining whether a PMA would be required for most of the remaining devices [50].

View Article: PubMed Central - PubMed

Affiliation: Health Research Group at Public Citizen, Washington, DC, United States of America. jonas.hines@ucsf.edu

ABSTRACT

The number and complexity of medical devices have increased over the past several decades. A series of recent safety issues have raised public awareness about shortcomings in the Food and Drug Administration's (FDA) regulation of medical devices.

We provide a background on medical device premarket review and identify eight addressable weaknesses in the process.

These include a lower approval standard than their drug counterparts, excessive reliance upon a fast-track process, and failure to conduct Congressionally mandated device classifcations.

Paradigmatic cases drawn from recent Food and Drug Administration regulatory proceedings illustrate each weakness.

Show MeSH