ComplianceOnline

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

Instructor: David Dills
Product ID: 701907
  • Duration: 60 Min

Training CD

$500.00
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(For multiple locations contact Customer Care)
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Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

Learn about the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.

Why Should You Attend:
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. 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.

Areas Covered in the Seminar:

  • 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 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

Instructor Profile:
David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones.

David has been previously affiliated with well-known device manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and expertise.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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