Decision Diagnostics Corp (DECN)

[Raffis]

FDA RUO LOOKS GOOD. I. Introduction: https://www.fda.gov/media/87374/download
FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products1 are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO)2. FDA is concerned 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 use3), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are
1 “In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.” Title 21, Code of Federal Regulations (CFR), section 809.3(a).
2 This guidance is only intended to apply to IVD products that have not been approved, cleared or licensed for any use, and it is not intended to address off-label uses of any approved, cleared or licensed products.
3 Throughout this guidance document, references to “clinical diagnostic use” and “use in clinical diagnosis” include use in making medical treatment decisions.
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Contains Non-binding Recommendations
inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products. FDA is issuing this guidance to clarify the requirements applicable to RUO and IUO IVD products, including that RUO and IUO labeling must be consistent with the manufacturer’s intended use of the device.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Regulatory Requirements for Research Use Only and Investigational Use Only IVD products
Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510, 515, 520(g)(2)(A) of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a). A product’s intended use refers to the “objective intent” of those responsible for labeling the product.4 Intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.5
Device Investigations Subject to IDE Regulation
FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. See 21 CFR 812.7.
Device Investigations Exempt from IDE Regulation
Investigations of diagnostic devices that meet the criteria at section 812.2(c)(3) are exempt from the regulations at 21 CFR 812, with the exception of section 812.119. The criteria at section 812.2(c)(3) include specifying that testing:
4 See, 21 CFR 801.4 5 See, id.
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Contains Non-binding Recommendations
• be non-invasive,
• not require an invasive sampling procedure that presents a significant risk,
• not by design or intention introduce energy into a subject, and
• not be used as a diagnostic procedure without confirmation of the diagnosis by
another, medically established diagnostic product or procedure.
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.''
(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.''
For purposes of this guidance document, "labeled RUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(i); "labeled IUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(ii) unless otherwise specified. Examples of products that meet the criteria for these designations are provided in Section III.
Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses.
Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.
In general, if evidence shows that an IVD product is inappropriately labeled RUO or IUO, and that the product does not qualify for an investigational device exemption under 520(g) of the Act, and is not cleared, approved, or 510(k)-exempt, the device would be misbranded under sections 502(a) and 502(o) of the Act, 21 U.S.C. 352(a), 352(o), and adulterated under section 501(f) of the Act, 21 U.S.C. 351(f).