Straight Talks: New players, new rules - IP disruption in the automobile industry
On March 1, 2024, the US Department of Commerce’s (“Commerce”) Bureau of Industry and Security (“BIS”) published an Advance Notice of Proposed Rulemaking1 (the “Notice”) seeking public comments on potential regulation of the...more
Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more
On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more