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Of course I don't know the particulars of anyone's specific situation, other than my understanding of the brief discussions posted here. All that I can do is help to point out the published rules and other information that seems applicable.
The following text from the 2011 US FDA draft IVD Research Use Only FAQ actually applies to all devices, and describes the basis for the Investigational Device Exemption:
You said:
The regulatory boundaries are defined in 21CFR 812.2 "Applicability". I'd suggest that you memo-to-file the specific exemption justification that you have determined applies from 21CFR 812.
For instance, maybe your devices qualify as "custom".
21CFR 812.3 defines "Custom device" to be a device that:
The following text from the 2011 US FDA draft IVD Research Use Only FAQ actually applies to all devices, and describes the basis for the Investigational Device Exemption:
Section 520(g) of the Federal Food, Drug, and Cosmetic Act ("the 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 and 515 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. Intent is determined by such persons? expressions or may be shown by the circumstances surrounding the distribution of the article.
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 practices by sponsors and investigators pertaining to the marketing and distribution of investigational devices. See 21 CFR 812.7.
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 practices by sponsors and investigators pertaining to the marketing and distribution of investigational devices. See 21 CFR 812.7.
since it's class II, an IDE is not needed for the restricted small-scale use that the device is being used for.
For instance, maybe your devices qualify as "custom".
21CFR 812.3 defines "Custom device" to be a device that:
(1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.