Who should attend
This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
- Regulatory Affairs Officers
- Regulatory Affairs Executives
- Regulatory Affairs Managers
- Quality Assurance Managers
- Quality Assurance Officers
- Members of the Senior Management Team
- Product Management professionals
- Design & Development Engineers
Book onto this course
- 21st & 22nd February 2012 – 510K01/02/12
- 10th & 11th October 2012 – 510K01/10/12
Course Outline
This highly informative and interactive course is designed for those companies either planning to sell or contemplating selling their medical devices into the USA. Aimed at all levels of regulatory staff and also senior management, this course gives an in depth review of the Pre Market Notification registration process, otherwise known as a 510(k).
The registration process of medical devices for sale in the United States of America requires the products to be registered with the Food & Drug Administration (FDA). There are two major approaches for complying with this requirement; a Pre-Market Notification 510(k) registration or a Pre Market Approval (PMA). This course covers identifying which approach should be taken under what circumstances and then focuses on often preferred 510(k) route. This course assists with understanding terminology such as ‘substantial equivalence’, how the FDA interpret it, and guidance in deciding if your product is or is not substantially equivalent.
Our course walks you through the entire 510(k) process from ensuring that 510(k) is the right route for you, to understanding what should be submitted in the 510(k) file, how it should be submitted, what the FDA expect to see covered, your design history file, how to handle queries raised by the FDA and the timescales involved including those that you have to meet.
With many real life examples, our course is delivered by experienced regulatory experts who have successfully registered medical devices with the FDA and regularly assist clients with their 510(k) and PMA applications.
Topics covered include
- FDA Organisation
- FDA device classification
- 510(k), PMA and alternative routes
- The 510(k) process
- Substantial equivalence
- The contents of a 510(k) file
- The regulatory framework within which the process operates
- Device History Files and design considerations
- Quality Assurance considerations 21 CFR 820
- The power of the FDA
Outcomes
At the end of the course, delegates will gain a detailed knowledge of:
- Deciding which route to take to sell into USA
- What is required in the 510(k) file
- How to complete a 510(k) application
- Contents of the Design History File
- Overview of Quality Assurance requirements 21 CFR 820
Venue
- Holiday Inn, Birmingham, UK
- Close to Birmingham International Airport & International train station (with free shuttle bus)
- 1 minute from junction 6 of the M42
