Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff | Guideline Explorer

Description

FDA is issuingthis guidanceto inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA-regulatedin vitrodiagnostic (IVD) device investigations. As described below, FDA does not intend to object to the use, without informed consent, of leftover human specimens -- remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded -- in investigations that meet the criteria for exemption from the Investigational Device Exemptions (IDE) regulation at 21 CFR 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not individually identifiable. FDA also intends to include in this policy specimens obtained from specimen repositories and specimens that are leftover from specimens previously collected for other unrelated research, as long as these specimens are not individually identifiable.

Scope & Applicability

Product Classes

1

In Vitro Diagnostic Device

IVDs for emerging pathogens during a Section 564 declared emergency

Stakeholders

2

Institutional Review Board

Governs top dose in clinical studies

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

1

Not Individually Identifiable

specimens that are not individually identifiable

Related CFR Sections (4)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR809.3§ 809.3 Definitions.
(a) 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 Read full regulation →
21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →

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