FDA Circular: Guidelines on the Maintenance of Importation and/or Distribution Records, and the Reporting of Product Complaints, Adverse Events, and Field Safety Corrective Actions for Medical Devices; (15 page(s), in English)

Partial amendment to the Minimum Requirements for Biological Products Partial amendment to the Public Notice on National Release Testing.; (1 page(s), in English)

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices (COM(2024) 43 final); (26 page(s), in English)