Hello Anon,
Just to add what has already been provided - there is a difference between Research Use Only (RUO) and Investigational Use Only (IUO) concerning in vitro medical devices (IVD). RUO is just that - research - it is not used with, on, or in patients. IUO are investigational meaning they are being used with human specimens as part of a clinical investigation or clinical trial. Carol provided the reference to 21 CFR Part 812 for how research and investigational use products are to be labelled.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-May-2023 11:42
From: Carol Castillo
Subject: During IUO reagent testing, what label shall be put on the instruments used for the testing? RUO? or IUO?
Assuming testing will take place in the United States, the label on the instrument is independent from the label on the reagent. While the reagent may be used for IUO (Investigational Use Only), the instrument could well have been previously cleared by the FDA. See below breakdown.
Instruments Cleared under 510(k) or De Novo requests.
Must bear label under which it was cleared and comply with 21 CFR 801 and 21 CFR 809.10.
Class I Instruments or 510(k) exempt Class II
Label must comply with 21 CFR 801 and 21 CFR 809.10.
Class II Instrument (not cleared by FDA) used in Investigational Studies to Support Future Regulatory Submission
Label must comply with 21 CFR 812.5.
Class II Instrument (not cleared by FDA) used for R&D Purposes Only
The criteria in section 812.2(c)(3) also include compliance with labeling requirements
section CFR 809.10(c), which exempts shipments and other deliveries of IVDs from certain
labeling requirements if either (1) the device complies with part 812, or (2) the investigation
is not subject to part 812 and one of the following conditions is 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.''
The FDA Guidance Document further expands on this subject: https://www.fda.gov/files/medical%20devices/published/Distribution-of-In-Vitro-Diagnostic-Products-Labeled-for-Research-Use-Only-or-Investigational-Use-Only---Guidance-for-Industry-and-FDA-Staff.pdf
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Carol
Original Message:
Sent: 09-May-2023 10:00
From: Anonymous Member
Subject: During IUO reagent testing, what label shall be put on the instruments used for the testing? RUO? or IUO?
This message was posted by a user wishing to remain anonymous