[Histonet] FDA Final Rule

[Histology]

Hello Histo World,

Is anyone out there still using RUO or IHC antibody not approved by the FDA?  If so, what are your plans moving forward?  Any idea how much it costs to register with the FDA as a device manufacturer and what each antibody will cost?  I've watched all the webinars but I still have so many questions.  I want to know how other labs are responding.

Thank you for responding,

Mehndi Helgren
Lab Manager
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA  23510