News In Brief
This article was originally published in The Silver Sheet
Executive Summary
Senators want to know why it’s taking so long for the Office of Management and Budget to release FDA’s proposed UDI rule; CDRH’s 2013 budget increase would come from industry.
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Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’
CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative that encourages companies to make quality assurance an organization-wide concern. Since FDA directed firms in 2009 to write FDA-483 response letters within 15 workdays after an inspection, the agency has been concerned that companies might feel compelled to fix every citation listed on the inspection form quickly without considering root causes. “What we are worried about is that this perceived need to respond in such a manner may prevent firms from taking time for a greater root cause assessment of the systemic problems that gave rise to the FDA-483 citations,” CDRH Office of Compliance Director Steven Silverman said. The Case for Quality will also examine how companies are inspected and how to make device quality data more accessible to firms.
News In Brief
ISO 13485 will be baseline for IMDRF single-audit work plan; U.S. Marshals seize ultrasound gel made by Pharmaceutical Innovations ISO 13485 will be baseline for IMDRF single-audit work plan.
CDRH And Industry Action Spurs Largest Annual Device Recall Count In FDA History
Device recalls increased 33 percent in 2011 because of FDA’s work to reduce a backlog of unclassified recalls, manufacturer concern about nonconforming products and the agency’s sharp focus on radiological device safety, among other explanations. “The elimination of the recall backlog in ORA and the center, as well as enhanced industry reporting, were big factors across all FDA-regulated products,” said Ann Ferriter, director of the Division of Risk Management Operations in CDRH’s Office of Compliance. And the center is continuing to improve: In the first quarter of FY 2012, it achieved an 80 percent on-time classification rate thanks to work by its “Recall Process Improvement Project,” which is due to wrap up by Oct. 31. In related news, Congress may consider legislation requiring FDA to establish a program to routinely assess recall information, and ORA is looking to beef up its recall audit check process.