FDAs Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
Learn when and how to register a device establishment and list devices with FDA, what the final rule changed, and how the rules apply to imported devices.
Speaker
David R. Dills
Global regulatory affairs consultant · 35+ years in regulatory affairs
Overview
Establishments that produce or distribute medical devices for the U.S. market must register with FDA every year, and most must also list the devices made there and the activities performed on them. This 60-minute webinar on FDA device establishment registration and listing gives an overview of how to register and list correctly.
You'll review the rulemaking: the proposed rule's four types of changes, including aligning the regulations with the 2007 FDAAA electronic registration provisions, making some requested information mandatory, and collecting information on imported devices under the 2002 Bioterrorism Act.
The final rule requires information beyond the earlier regulations that FDA already requested through FURLS. The session also covers updating listings outside required periods and who must provide registration numbers.
Why attend: Registration and listing errors can affect your ability to market devices in the U.S. This session gives a start-to-finish refresher on the process so you meet FDA's requirements and expectations. It suits device firms, importers, distributors and authorized representatives, and staff in regulatory affairs, quality and compliance, marketing and sales, legal, engineering and operations, as well as consultants in medical device, biotech and pharma.
What’s covered
- When and how to register and list
- The four major changes to FDA's device establishment registration and listing regulations
- Consistency with the 2007 FDAAA electronic registration and listing provisions
- Information that moved from requested to required
- Implementing Bioterrorism Act provisions for imported devices
- Other amendments to registration and listing requirements
- Updating device listing information outside the required update periods
- Who must provide establishment registration numbers
Who should attend
What you get
About the speaker
David Dills is currently a Global Regulatory Affairs Consultant after departing his last company earlier this year in 2024 and a full-service CRO as Director of Regulatory Services. He is a seasoned Global Regulatory Affairs, Regulatory Strategist, and Compliance professional with demonstrated capabilities and a track record with more than 35 years of accrued experience in the functional areas of Regulatory Affairs, Regulatory Intelligence, Regulatory Compliance, Global Regulatory PM/PD, and QA/QAE for US and international developers/manufacturers/sponsors for early-stage, mid- and large-size enterprises for pharma, biologics, combination, and medical device products from investigational to marketing approval. He has worked for CROs, consultancies, and manufacturers in different roles and capacities. A key focus is regulatory strategy and bringing products from new product development from pre-clinical to global market transfer and commercial release and collaborating with the regulatory authorities and agencies. With his depth and breadth of regulatory and compliance experience, he examines all aspects of regulatory and compliance, to help companies uncover potential strategic regulatory risks while cultivating novel, targeted strategies to help companies achieve regulatory approval in multiple markets. This is to ensure that regulation provides consistent strategic messaging and cohesion throughout the entire regulatory and compliance lifecycle for the key stakeholders of the organization. He manages regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities. He enjoys developing and executing comprehensive regulatory strategies for companies, considering their specific business objectives regulatory requirements, and commercial considerations in global markets, and supporting sound regulatory submissions, interactions, and outcomes with regulatory authorities. This includes leading the interactions with Health Authorities on behalf of companies in formal meeting settings, including providing pre-meeting coaching and preparation of briefing documents, negotiations, and post-filing support. He enjoys providing regulatory leadership experience with a broad spectrum of indications, therapeutic areas, and product modalities at multiple phases. He has academic degrees in Biology and Environmental Science and is an active member in various professional industry groups and affiliations.
Danielle DeLucy · 60 min
Edwin Waldbusser · 60 min
Ginette M. Collazo · 90 min