The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices.
- 27 Mar 2020US Naval Ships Mercy and Comfort using HIN to expedite receiving pharmaceutical supplies to support NYC and LA hospitals fighting COVID-19
- 27 Mar 2020ANSI recognizes HIBCC support of the fight against COVID-19
- 25 Mar 2020European Commission delays its MDR by one year to focus on the Coronavirus, but leave labeling and database compliance deadlines unchanged.
- 20 Mar 2020HIBCC’s HIN System supporting healthcare supplier efforts to fight COVID-19
- 20 Mar 2020HIBCC releases new website page on HIN and DSCSA