FDA Leftover Specimen Consent Guidance

01 What the document says

FDA's informed consent regulations apply to clinical investigations of devices, including IVD studies that use human specimens. This guidance states that FDA does not intend to object when an IVD investigation uses leftover specimens without informed consent, provided a defined set of conditions is met. It is directed at sponsors, IRBs, clinical investigators, and FDA staff and remains in effect.

The conditions are specific. The study must be exempt from the IDE regulation under the provision covering diagnostic devices that are non-invasive, do not require invasive sampling presenting significant risk, do not introduce energy into the subject, and are not used as a diagnostic without confirmation by an established method. The specimens must be leftover: remnants of specimens collected for routine clinical care or for other research that would otherwise be discarded. They must not be individually identifiable to anyone involved in the study, with the guidance describing acceptable de-identification practices and the role of an honest broker. Specimens from repositories can qualify. The policy covers the consent requirement only; IRB review of the investigation is still required.

FDA has since reiterated, in a letter to industry, that studies using leftover de-identified specimens still require IRB review, and sponsors have been asked to document that review in their submissions. The guidance does not address prospective collection of specimens for the study, which requires informed consent in the ordinary way.

02 What it means when you plan a study

• Leftover, de-identified specimens can supply positives for rare analytes or off-season pathogens without a consent process, but only for IDE-exempt studies and only with IRB review documented in the submission.
• Specimens must truly be remnants destined for discard; a protocol that asks a laboratory to draw an extra tube or aliquot before the clinical result is reported is a prospective collection and needs consent.
• De-identification must be irreversible from the study team's perspective; the chain of custody and coding scheme should be written down and approved by the IRB before the first specimen moves.
• Clinical performance claims typically require prospective fresh specimens from the intended-use population, so leftover specimens are usually a supplement for analytical or enrichment purposes, not the whole clinical study.
• Sites with an existing IRB-approved umbrella protocol for leftover specimen use can start supplying specimens in weeks; without one, the IRB cycle is on the critical path.

03 Pathways it applies to

• 510(k) Clinical Studies
• CLIA Waiver Studies
• Dual Submission Studies

Source document: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (fda.gov).