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