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

FDA encourages third party inspections

This article was originally published in Clinica

Executive Summary

The FDA has issued guidance effectively encouraging the use of third parties to inspect medical device facilities. The agency has come under fire for failing to inspect enough facilities both in the US and abroad, particularly China, and greater use of accredited third parties to carry out inspections would ease up FDA resources.