FDA’s New Rule for Establishment Registration and Device Listings

OVERVIEW Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Initially, FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule). The Proposed Rule contains four types of proposed changes to FDA’s device establishment registration and device listing regulations.
WHY SHOULD YOU ATTEND
This Webinar will provide latest update as well as a “refresh” overview on how to register your device company and list your device(s) correctly and meeting requirements and expectation regardless of the outcome of the Final Rule.
AREAS COVERED
• When and how to register and list
• Review the four major changes to FDA’s device establishment registration and device listing regulations
• Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices
• Other proposed Amendments that would change current device establishment registration and listing requirements
• Replacement of the current regulations regarding updating device listing information outside the required update periods
• Clarification of who must provide establishments’ registration numbers
LEARNING OBJECTIVES
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).
WHO WILL BENEFIT
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

For more detail please click on this below link:
https://bit.ly/2qCZ5sF

Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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