FDA’s Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List – By Compliance Global Inc.



Speaker: David R Dills


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.

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.

Why Should You Attend:

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. The Proposed Rule, if finalized, would require establishments to provide additional or different information than specified in the current regulations, but which FDA now requests via FURLS. This Webinar will provide latest fda training 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 Proposed Rule.

Areas Covered in this Webinar:

• When and how to register and list
• Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices
• Other proposed Amendments that would change current fda rules and regulations and listing requirements

Learning Objectives:

• Review the four proposed changes to fda medical device regulations on fda registration and listing
• Replacement of the current regulations regarding updating fda medical device listing information outside the required update periods
• Clarification of who must provide establishments’ registration numbers

Who Will Benefit:

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

For more information, please visit https://www.complianceglobal.us/product/700268

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Ad Reference ID: 18856695f9e02fd1

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