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

Snapshot: 2015 Medical Device Quality-Related Warning Letters

This article was originally published in The Gray Sheet

Executive Summary

A "Gray Sheet" analysis has discovered that the industry racked up its fewest number of FDA quality-related warning letters in nearly a decade. The agency released 74 warning letters to its website in calendar year 2015 that included at least one quality system violation. Other findings: letters to foreign firms is down; CAPA is the most-oft cited violation; and close-out letters hit a new peak. And check out our infographic, which includes a listing of where non-US letters went last year and a breakdown of other data.