Several updates for our clients in the Healthcare and Medical Devices industries:
Federal Register Notice for Final Rule – FDA Destruction of Medical Devices
The FDA has issued a final rule effective July 1st, 2024, for administrative destruction of certain medical devices valued at $2500 or less that are refused admission into the US. The rule provides owners or consignees with notice and an opportunity to present testimony before the destruction of the device. The rule was modified to include refused medical devices since originally it only applied to refused drugs.
Full details of the final rule can be found here.
Important Orange Book Facts Webinar
The FDA has also announced some Continuing Education webinars with the first topic being Important Orange Book Facts. The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved based on safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The purpose of this webinar is to discuss commonly asked questions about the Orange Book. Topics will include Orange Book content and format and how to use the Orange Book to find information on therapeutic equivalence, marketing status, patents, and exclusivities.
To register, please use this link.
New Regulations for Medical Gases
The FDA has announced a final rule that establishes certification regulations for certain medical gases and amends the requirements for current good manufacturing practices (CGMP), post marketing safety reporting, and labeling. Once published, the document will be available here.
