FREQUENTLY Asked Questions
In what circumstances does FDA intend to exercise enforcement discretion as to the requirements for informed consent for use of specimens in FDA regulated IVD studies?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

FDA intends to exercise enforcement discretion as to the informed consent requirements for clinical investigators, sponsors, and IRBs if an in vitro diagnostic device investigation is performed and all of the following are true:

  • The investigation meets the IDE exemption criteria at 21 CFR 812.2(c)(3).
  • The study uses leftover specimens, that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded. The study may also use specimens obtained from specimen repositories or leftover specimens that were previously collected for other research purposes.
  • The specimens are not individually identifiable, i.e., the identity of the subject is not known to and may not readily be ascertained by the investigator or any other individuals associated with the investigation, including the sponsor. If the specimen is coded, it will be considered to be not individually identifiable if neither the investigator(s) nor any other individuals associated with the investigation or the sponsor can link the specimen to the subject from whom the specimen was collected, either directly or indirectly through coding systems.
  • The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor.
  • The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation.
  • The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information.
  • The study has been reviewed by an IRB in accordance with 21 CFR Part 56.

Studies that do not fall within the intended enforcement discretion expressed in this guidance include (but are not limited to) studies where any of the following is true:

  • The study does not meet the IDE exemption criteria at 21 CFR 812.2(c)(3).
  • The specimens are individually identifiable, i.e., the identity of the subject is known to or may be readily ascertained by the investigator or any other individuals associated with the investigation, including the sponsor.
  • The specimens were collected specifically for the proposed investigation. That is, the specimens are not leftover from routine clinical care or analysis or leftover from other research.
  • The amount of specimen needed for the study is more than would be leftover from what is usually collected for routine clinical analysis.
    OR
  • The test results will be reported to the subject’s health care provider. For example, in the course of comparative studies involving B. anthracis detection devices, it would be inappropriate not to report positive results if they occur in the course of an investigation.

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