IVD Clinical Trial Regulations

Goals

To understand the FDA's clinical trial regulations for IVD (in vitro diagnostic) devices, especially where they might differ from regular pharmaceuticals.

Early Findings

  • The FDA defines IVD devices as "devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act."
  • IVD devices are "like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988."
  • They are broken into Class I, Class II and Class III depending on the level of control needed to assure safety and effectiveness.
  • IVDs and all other medical devices are subject General Controls. IVD devices are also subject to CLIA classification.
  • In 2018, the FDA issued new guidance for investigational IVD devices being used in clinical trials. "Based on concerns that drug clinical trial sponsors do not appreciate the need to follow device regulations when using “investigational” IVDs in clinical trials, the new guidance provides more structure around the incorporation of IVDs into clinical trials, and sets out FDA’s expectations about sponsor’s scope of review of the risk of use of such IVDs." The full guidance document from the FDA is available here.
  • Essentially, unless a device meets exemption standards, the sponsor must submit whether the device poses a significant or non-significant risk. An IRB must determine if they agree with the sponsor's rationale, and if not, the sponsor must obtain an NSR determination or an exemption.
  • In order to be exempt from IDE regulations, the device must be either: a pre-amendments device (pre-1976), substantially equivalent to a pre-amendments device, or properly labeled/noninvasive/no invasive sampling/no energy/not used for diagnosis without another medically-established diagnostic.
  • The FDA recently streamlined the process for IVD devices associated with cancer clinical trials.
  • The FDA's website highlights that drug and device approvals do follow the same basic steps, but processes do differ within those steps.

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