THE TOPIC

An overview of the US Food and Drug Administration’s medical device regulations and how to avoid the most common mistakes made by medical device exporters. This comprehensive, one-hour webinar will include:

– history of the FDA and the jurisdictional oversight of the CDRH (Center for Devices and Radiological Health)

– key medical device regulations, including the Food, Drug and Cosmetic Act

– pre-market requirements, registration, and US agents

– user fees

– medical device labelling requirements

THE SPEAKER

Cornelia Rooks worked for the FDA for 25 years. She retired in 2005 as the director of the Division of Device User Programs and Systems Analysis (DDUPSA). In 2006 she joined Registrar Corp, which provides registration, US agent, and compliance assistance for US and non-US companies in the medical device, drug and food and beverage industries.

WHO IS IT FOR?

Recommended for C-level executives; export sales personnel; quality control managers; and directors of clinical, medical, or regulatory affairs.

HOW IT WORKS

To register, email John Hoggard (Trade & Investment Officer, Life Sciences, UKTI New York) at john.hoggard@fco.gov.uk. We will send you a confirmation, plus a link and login details in advance of the webinar on 20 February 2013.

You can easily take part in the webinar from any computer – all you need are an internet connection and a phone line. You do not need to download specific software.

Commercialising your medical device in the US – How to avoid common mistakes in complying with FDA requirements