| Title: | FDA Guidance Regarding Importation of Certain Research Use Only (RUO) Medical Device Products Used For Non-Clinical Purposes |
|---|---|
| Date: | 2011-04-19 |
| To: | abi |
| Links: | previous, next |
The Food and Drug Administration (FDA) is notifying all ABI filers of the creation of six new product codes to facilitate the import entry process for certain Research Use Only (RUO) products. Shipments of RUO products must be declared to FDA and may not be disclaimed.
FDA's Center for Devices and Radiological Health (CDRH) is utilizing enforcement discretion to not require foreign device manufacturers and exporters of certain RUO products to register and list as required by 21 CFR §807.40. Such establishments are not exempt from registration because 21 CFR §807.65(f) does not apply to foreign establishments.
The product codes must only be used when declaring the importation of certain RUO products.
Research Use Only products are those products that are in the laboratory research phase of in vitro diagnostic product development, or are intended to be used in basic scientific research for the purpose of knowledge generation. These products may include instrumentation, reagents, equipment, and other similar articles that are either in product development or are used for basic research.
Any in vitro diagnostic product intended for use in a clinical investigation or for clinical diagnostic use outside an investigation (for example, in clinical diagnosis) should not be labeled For Research Use Only..
Each RUO product needs to comply with the labeling requirements listed in 21 CFR §809.10(c)(2)(i), which states, "For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed:
"For Research Use Only. Not for use in diagnostic procedures."
FDA will be monitoring the use of these six codes and will take appropriate regulatory action against anyone who misuses them.
The six new FDA Product Codes are:
Device/Product Name FDA Product Code
Research use only/hematology devices 81O--TQ
Research use only/immunology devices 82O--TR
Research use only/microbiology 83O--TT
Research use only/pathology 88O--TU
Research use only/clinical chemistry devices 75O--TV
Research use only/clinical toxicology 91O--TW