Ropes & Gray: FDA Draft Guidance Would Restrict Marketing of Research Use Only and Investigational Use Only In Vitro Diagnostic Products | Practical Law

Ropes & Gray: FDA Draft Guidance Would Restrict Marketing of Research Use Only and Investigational Use Only In Vitro Diagnostic Products | Practical Law

This Ropes & Gray LLP memorandum discusses the Food & Drug Administration (FDA) draft guidance document setting forth the agency's proposed interpretation of the law regarding commercially distributed in vitro diagnostic (IVD) products labeled for research use only (RUO) or investigational use only (IUO).

Ropes & Gray: FDA Draft Guidance Would Restrict Marketing of Research Use Only and Investigational Use Only In Vitro Diagnostic Products

by Ropes & Gray LLP
Published on 16 Jun 2011USA (National/Federal)
This Ropes & Gray LLP memorandum discusses the Food & Drug Administration (FDA) draft guidance document setting forth the agency's proposed interpretation of the law regarding commercially distributed in vitro diagnostic (IVD) products labeled for research use only (RUO) or investigational use only (IUO).