Process For Appealing FDA Actions To Be Clarified, CDRH Ombudsman Says
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center is reworking procedures for resolving disputes between industry and FDA reviewers, and expanding the types of regulatory actions that can be appealed.
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Regulatory News In Brief
CDRH ombudsman report: The number of external complaints, disputes and inquiries fielded by the FDA device center's ombudsman jumped 47% in 2009, from 170 to 250. 70% of the contacts came from industry and 17% originated with consumers, according to the 2009 CDRH ombudsman 1report, released last week. More than 50% of the contacts involved complaints. A number of the items fielded concerned 510(k)s (15%) and pre-market approval applications (9%). In addition, most centered on staff or issues within the Office of Device Evaluation (54% of contacts), Office of Compliance (17%) or Office of Management Operations (9%). Commonly raised issues related to CDRH policies and procedures, pre-market testing requirements (and whether FDA was truly requiring the "least burdensome" amount of data), miscommunication and a lack of timely action. The vast majority of items (92%) were addressed within the year. The ombudsman received only one request for review of a scientific dispute by the Medical Devices Dispute Resolution Panel; CDRH is attempting to resolve the matter by other means. After nearly a decade helping resolve problems between regulators and industry, CDRH Ombudsman Les Weinstein will leave the post April 9 to join FDA's newly created tobacco products center
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