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.
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.
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
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.
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
David R. Dills
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, …
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