FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

Duration: 60 Minutes
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.
Device Establishment Registration
Instructor: David R Dills
Product ID: 500074
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. 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 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.

Objectives of the Presentation:
  • When and how to register and list
  • Review the four proposed 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
Who can 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
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$375
Recorded Session for one participant
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Recorded Session - How it works
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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