Month: February 2025
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Plenary Session 2
‘Across the Recall Ecosystem: Leading Practices, Challenges & Lessons Learned’ Plenary session 2: ‘Across the Recall Ecosystem: Leading Practices, Challenges & Lessons Learned’ featured speakers from Costco, Peloton and Health Canada, and was moderated by a representative from the Retail Industry Leaders Association. The panel discussed best practices in product […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Plenary Session 1
‘Market Surveillance and Product Recalls: Linking Policy to Action in Case of Online Sales’ Plenary session 1 featured speakers from Amazon, TIC Council Americas, UL Solutions and Anushi Amin of Cooley (UK) LLP. The panel examined how the new European Union (EU) General Product Safety Regulation (GPSR) would affect the […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium
Cooley’s international products team will be attending the ICPHSO 2025 Annual Meeting and Training Symposium, “Fostering Bridges Within the Product Safety Community,” in Orlando, Florida, from February 17 – 20, 2025. We will be posting highlights from the plenary panel sessions on our Productwise blog throughout the event.
European Commission Publishes Guidance on EU Batteries Regulation Removability Requirements
New European Commission (EC) guidance on the European Union Batteries Regulation 2023/1542 has been published, which is relevant to anyone who places products containing batteries on the EU market. The new guidance sheds light on the challenging Article 11 requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.
Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel