Straight Talks: New players, new rules - IP disruption in the automobile industry
On March 7, 2025, the FTC filed a complaint in federal court seeking to block GTCR BC Holdings, LLC, a Chicago private equity firm, from acquiring Surmodics, Inc. The FTC alleges that Surmodics is the leading provider of a...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Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more
In December, my colleague Aaron Josephson and I described our observations after attending FDA’s public workshop on Medical Device Servicing and Remanufacturing Activities. In this post, I want to share some additional...more
On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance,...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