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. For example, Proposed Rule would amend FDA's current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. Second, the Proposed Rule would require establishments to provide certain information that FDA currently requests when the establishment registers or lists a device, but is not mandatory. Proposed Rule would also amend the regulations to facilitate FDA's collection of information from foreign establishments regarding their devices that are imported into the U.S. as required by the 2002 Bioterrorism Act and other proposed changes to be addressed. 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.