Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Domestic, Foreign Manufacturers Achieve Virtual Quality-Related FDA Warning Letter Parity; Missive-Counting Methodologies Explained

This article was originally published in The Gray Sheet

Executive Summary

Quality-related warning letters sent to foreign device manufacturers are on the rise, FDA data shows: 62 domestic and 59 non-US firms received letters that included at least one violation of the Quality System Regulation. Also: FDA's yearly warning letter count has closely mirrored separate analyses by The Gray Sheet for more than a decade, yet over the past two years those counts have wildly diverged; we explain why.

Advertisement

Related Content

Adverse Events Stack Up At FDA; 2016 Warning Letter Data Show Troubles With MDRs, Complaints

Topics

Advertisement
UsernamePublicRestriction

Register