August 22, 2014

FDA to Medical Device Industry: Slow 510(k) Process is Your Fault

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA is going Peter Finch in Network on us. They’re mad as hell, and they aren’t going to take it anymore.

Hit by recent studies claiming the 510k review process is slowing and that the agency is largely to blame, the FDA has struck back with its own study that basically say the medical device industry is the villain because it does a lousy job with its submissions.

For those keeping score at home, the FDA’s new study essentially lays a bit over 80% of the blame on industry, and says it’s responsible for some of the rest.

Two separate analyses of AI Letters were conducted in the FDA study: one to assess incoming submission quality (Cohort 1) and one to assess the drivers of the increasing numbers of review cycles (Cohort 2).

“Results indicate that 83% of the submissions in Cohort 1 and 82% of the submissions in Cohort 2 contained at least one deficiency related to quality, as defined below. The remainder of the submissions in each cohort had deficiencies that fell outside the conservative definition of quality used in this report. In Cohort 1, 52% of these quality issues involved the device description, meaning the sponsor either did not provide sufficient information about the device to determine what it was developed to do, or the device description was inconsistent throughout the submission. Like Cohort 1, the Cohort 2 analysis shows that roughly 50% of submissions that received at least one AI Letter lacked an adequate device description.”

But former FDA inspector (and my fellow AssurX blogger) Patrick Stone isn’t buying the FDA’s interpretation and thinks they are leaving a few key elements out of its analysis. “The stats will show that there are many thousands of submissions in line for review or audit.  More than FDA can handle…that is one issue,” Stone notes.

Another problem: “The FDA device Experts can not readily keep up with the technology so there is the on the job training for FDA at inspection time and slow center review cycle.”

Stone’s solution? “FDA needs to provide comprehensive BIMO device guidance and cradle to grave expectations.  The game gets changed half way through the development cycle so that what was compliant four years ago is now not.”

I’m not sure how much it will help, but the FDA is getting support from some Democrats in DC, who also question some of the studies critical of the agency.

This battle ain’t over. Watch this space.

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