Replacement reagents
This article was originally published in The Gray Sheet
Executive Summary
Updated 1Replacement Reagent & Instrument Family Policy Guidance notes that manufacturers "no longer need to submit an add-to-file prior to marketing different reagent/instrument combinations (including new family members) when both have been previously cleared." The December document, which includes replace reagent and instrument terminology and discusses CLIA categorization and special 510(k)s, supersedes a June 1996 guidance (2"The Gray Sheet" Sept. 15, 1997, I&W-4)...
You may also be interested in...
Revised secondary reagents guidance will address IVD performance criteria -- FDA's Gutman.
IVD SECONDARY REAGENT GUIDANCE REVISIONS TO BE COMPLETED in the next several weeks, FDA staffers say. The changes seek to clarify two provisions of the June 1996 guidance, Steve Gutman, director of the Division of Clinical Laboratory Devices in FDA's Center for Devices and Radiological Health, said Sept. 8 at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.