Read research-only use cases

[bsima]

Read and analyze this: "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions".

[bsima]

Here are the requirements for RUO devices: http://www.ecfr.gov/cgi-bin/text-idx?SID=4c9e88f3ded35e3b02fd041d09b83409&node=pt21.8.812&rgn=div5

[bsima]

I should print the above two documents out and read them offline for better comprehension, in fact that's what I'll do

[bsima]

21 CFR §809.10(c) is an important section:

(c) A shipment or other delivery of an in vitro diagnostic product shall be exempt from the requirements of paragraphs (a) and (b) of this section and from a standard promulgated under part 861 provided that the following conditions are met:

(1) In the case of a shipment or delivery for an investigation subject to part 812, if there has been compliance with part 812; or

(2) In the case of a shipment or delivery for an investigation that is not subject to part 812 (see §812.2(c)), if the following conditions are met:

(i) 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.”

(ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: “For Investigational Use Only. The performance characteristics of this product have not been established.”