Establishments that produce or distribute medical devices for the U.S. market must register with FDA every year, and most must also list the devices made there and the activities performed on them. This 60-minute webinar on FDA device establishment registration and listing gives an overview of how to register and list correctly.

You'll review the rulemaking: the proposed rule's four types of changes, including aligning the regulations with the 2007 FDAAA electronic registration provisions, making some requested information mandatory, and collecting information on imported devices under the 2002 Bioterrorism Act.

The final rule requires information beyond the earlier regulations that FDA already requested through FURLS. The session also covers updating listings outside required periods and who must provide registration numbers.

WHY SHOULD YOU ATTEND?

Registration and listing errors can affect your ability to market devices in the U.S. This session gives a start-to-finish refresher on the process so you meet FDA's requirements and expectations.

It suits device firms, importers, distributors and authorized representatives, and staff in regulatory affairs, quality and compliance, marketing and sales, legal, engineering and operations, as well as consultants in medical device, biotech and pharma.

AREA COVERED

• When and how to register and list
• The four major changes to FDA's device establishment registration and listing regulations
• Consistency with the 2007 FDAAA electronic registration and listing provisions
• Information that moved from requested to required
• Implementing Bioterrorism Act provisions for imported devices
• Other amendments to registration and listing requirements
• Updating device listing information outside the required update periods
• Who must provide establishment registration numbers

LEARNING OBJECTIVES

• Determine when and how to register an establishment and list devices
• Explain the major changes the rule made to registration and listing
• Apply the requirements for imported devices
• Update device listings outside the required update periods
• Identify who must provide establishment registration numbers

WHO WILL BENEFIT?

This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a refresh overview of the establishment registration and listing process from start to finish, including:

•     Regulatory Affairs
•     Quality and Compliance
•     Marketing & Sales 
•     Importers
•     Distributors/Authorized Representatives
•     Legal Counsel
•     Engineering/Technical Services/Operations
•     Consultants