FDAs Proposed Rule Regarding Device Establishment Registration and Listing - Webinar By ComplianceOn (Medical Device)
Venue: Online Event
|Event Date/Time: Mar 10, 2011||End Date/Time: Mar 10, 2011|
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 FDAâ€™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 â€œrefreshâ€ 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 FDAâ€™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 establishmentsâ€™ registration numbers.