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. For example, Proposed Rule would amend FDA’s current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. Second, the Proposed Rule would require establishments to provide certain information that FDA currently requests when the establishment registers or lists a device, but is not mandatory.

Proposed Rule would also amend the regulations to facilitate FDA’s collection of information from foreign establishments regarding their devices that are imported into the U.S. as required by the 2002 Bioterrorism Act and other proposed changes to be addressed. Final Rule requires establishments to provide additional or different information than specified in the current regulations, but which FDA now requests via FURLS.

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

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