FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologic Evaluation and Research (CBER) have issued a new guidance on Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only, formalizing a draft initially published for comment in June 2011.
In the introduction to the guidance, FDA reiterates its long-held concern that “the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic use), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product.”
The guidance is intended to clarify the requirements applicable to RUO and IUO products, “including that RUO and IUO labeling must be consistent with the manufacturer’s intended use of the device.”
The new guidance describes labeling and distribution practices considered appropriate for RUO and IUO products as well as practices that the agency considers inconsistent with those designations. Although the practices predominantly affect manufacturers, the actions of laboratory staff may influence whether the agency believes a product is inappropriately labeled. The guidance describes certification programs requiring labs not to use RUO or IUO products in a manner inconsistent with their labeling, but notes that the existance of such a program does not relieve manufacturers of their responsibilities for compliance.
Copies of the guidance document are available from the CDRH and CBER websites, or by email request to [email protected].
