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Medical Device Daily Washington Editor

The subject of the reliability of the 510(k) process has devoured thousands of hours inside and outside of FDA and gallons of ink in the print media, but a recent report commissioned by the Advanced Medical Technology Association (AdvaMed; Washington) suggests that widespread reports of "disastrous" device clearances are overblown. AdvaMed held a teleconference yesterday to roll out the results of the report, based on a study conducted by the research contractor Battelle (Washington), and the main point of emphasis was that only 0.16% of all 510(k) devices issued since 1998 were caught up in a class I recall.

The report echoes the theme of two reports filed for the review of the process by the Institute of Medicine (IOM), which has met on three occasions in preparation for its analysis of the clearance process. In one of those reports, Bill Maisel, MD, who is now employed at the agency's Center for Devices and Radiological Health (Medical Device Daily, Aug. 4, 2010), indicates that fewer than one in every 10 devices cleared as 510(k)s between 2003 and 2009 were the subject of a recall of any class.

David Nexon, Advamed's senior executive VP for policy, said on the conference call that the Battelle report and the two IOM reports "all . . . demonstrate a strong safety record" for the 510(k) process and that no prior criticisms of the program were based on hard data. AdvaMed said it intends to discuss the findings with FDA Commissioner Margaret Hamburg, MD, but as yet has no date for that meeting.

The 18-page report released by AdvaMed notes that Battelle collected data for class I recalls filed between Jan. 1, 2005 and May 1, 2010, and found that the average number of unique class I recalls per year was 15. The report notes further that FDA has cleared almost 47,000 devices since 1998 compared to slightly more than 2,800 PMAs, including panel-track and 180-day supplements. Class I recalls of the PMAs approved since 1998 came to 0.85%, more than five times the rate of the class I recalls for 510(k)s in the period studied.

Battelle found further that design issues drove more than half the 510(k) recalls, including issues associated with both original and changed designs. This category of recalls drove an even half of all PMA recalls captured in the Battelle study.

Slightly less than a fifth of the 510(k) recalls were categorized as those triggered by manufacturing issues, a group that includes problems under the quality system regulations and good manufacturing requirements. A third group, a catch-all basket of sorts, was labeled "manufacturing or design causes," explained in the report as consisting of recalls the cause of which is inferred due to lack of sufficient data to pin down a definitive cause. This category and labeling issues each accounted for fewer than one in seven class I recalls.

Class I recalls for both PMAs and 510(k)s triggered a market withdrawal in roughly two thirds of those recalls – 62% for cleared devices and 67% for approved devices – but the field action numbers diverge from there. Almost 20% of PMA class I recalls resulted in monitoring, perhaps a reflection of the higher rate of implants in this category, while only about 6% of 510(k) class I recalls were addressed by monitoring. Almost a quarter of 510(k) recalls were addressed via field fixes, four times the 5% rate that such measures were used for PMA recalls, and recalls of both classes of devices were addressed by labeling changes 9% of the time.

As one might expect, the traditional 510(k) was the primary driver of all device recalls (51%), while special 510(k)s and PMA devices each drove about 20%.

Mark McCarty, 703-268-5690

Published  September 16, 2010

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