AdvaMed Takes Issue with FDA ‘Conditions of Approval’ Report

In a recent letter, industry association AdvaMed (Washington, DC) took issue with a report from FDA’s Center for Devices and Radiological Health (CDRH; Rockville, MD), which, in the organization’s opinion, left the impression that medtech manufacturers demonstrated poor compliance with required condition of approval (COA) postmarket studies during a two-year follow-up evaluation.

The report, “Condition of Approval Studies as a Postmarket Tool for PMA Approved Cohort 1998–2000,” was released in late March of this year. During the period covered, CDRH reported, only 42% of the required studies were completed or were proceeding on schedule.

CDRH Director Schultz: Taking the heat.

In a letter to CDRH director Daniel G. Schultz, MD, AdvaMed’s associate vice president for technology and regulatory affairs Jeffrey Secunda said that “the characterization of the medical device industry as being substantially out of compliance is both inaccurate and unfair based on the full facts, which were easily obtainable from the sponsors of the cited PMAs.”

AdvaMed also criticized CDRH for continuing to publicize the findings, which it feels are a “misrepresentation,” along with the agency’s claim that it was difficult to obtain information regarding the status of the required COA studies.

AdvaMed conducted its own survey and found that “100% of the condition of approval (COA) studies required of the AdvaMed members cited in the FDA report have been accounted for and are in compliance with the PMA approval orders as issued or modified with the agreement of the agency.”

Specifically, AdvaMed reported that 12 of its member companies submitted 22 of the 45 PMAs that required COA studies. Of the 22, 16 were completed within the time frame expected by the agency, two were completed with delays of 3–12 months, two studies remain ongoing, one was cancelled, and one was suspended due to the sponsor’s inability to achieve adequate product distribution. According to AdvaMed, its members kept CDRH fully informed of the status of their COA studies throughout the period, regarding delay, continuation, suspension, or cancellation.

AdvaMed asserts that if CDRH had consulted with the sponsors of the studies, the agency would have had the opportunity to discuss the issue with appropriate personnel and create “a more accurate and complete report.”

AdvaMed acknowledged CDRH’s own recognition that the current system is lacking, and welcomed the opportunity to work with the agency to improve the tracking of COA studies.

According to a report not made public, Schultz has issued a directive to CDRH staff that they no longer cite the recent COA report.

© 2005 Canon Communications LLC

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