MEETINGS - US FDA 510(K) Submissions for Medical Devices, a Management Forum seminar (UK) January 2002:
This article was originally published in Clinica
Executive Summary
US FDA 510(K) Submissions for Medical Devices, a Management Forum seminar, will be held on January 17 2002 at the Harrington Hall, London. The objective of the seminar is to provide practical information regarding the preparation and content of pre-market notifications, 510(k)s. This will include an insight into the FDA's motivation when handling applications; the variety of 510(k)s available; alternative review mechanisms; implications of the mutual recognition programme and the procedures to be followed when a design or process alters. Further information from Management Forum on tel: +44 (0)1483 570 099; fax: +44 (0)1483 536 424; email [email protected] www.management-forum.co.uk