A Primer on Regulatory Strategy and Requirements
Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1bM6SeE email@example.com www.compliance4all.com
Overview: Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry. This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports and Exports. Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number, foreign establishment registration number and name of U.S. agent, medical device listing number, and Premarket Notification 510(k) or Premarket Approval number, if applicable. For exporting, while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical devices to be exported and the documentation process involved. Areas Covered in the Session: Examine the import and export requirements for medical devices Introduction to FDA references and guidance documents related to import and export requirements Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S. Import Alerts Recordkeeping requirements and your responsibilities How to export unapproved and approved medical devices Who Will Benefit: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales Distributors/Authorized Representatives Engineering/Technical Services/Operations Consultants Speaker Profile David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.
Tuesday, May 12, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Minutes