CDRH ombudsman’s report
This article was originally published in The Gray Sheet
Executive Summary
Number of contacts received by CDRH Ombudsman Les Weinstein in 2004 grew to 125, up from 120 in 2003, according to the 1ombudsman's annual report. Industry accounted for 90% of 2004 contacts, compared with 78% in 2003 (2"The Gray Sheet" April 5, 2004, p. 8). The Office of Device Evaluation remains the office most often involved with disputes/complaints (66%). Premarket notifications are still the most cited subject for disputes/complaints (28%), while inspections (4%) and HDEs (2%) were added to the list for the first time in 2004. Miscommunication or lack of communication continues to be the top reason for complaints/disputes (25%), followed by "least burdensome" issues (16%). By the end of 2004, about 35% of complaints/disputes were pending, 31% resolved, 21% withdrawn or not followed-up and 13% referred outside CDRH. In 2003, 26% were resolved and 22% were pending...
You may also be interested in...
Device Center Disputes And Complaints Increased In 2003 – Ombudsman
The number of complaints received by CDRH Ombudsman Les Weinstein roughly tripled last year
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.