Early Clinical Evaluation Of Medical Devices In USA: FDA Issues Draft Guidance Document

In case you’ve ever wondered how new medical devices gain access to the clinical field in the United States, the Food and Drug Administration(FDA) has issued a draft guidance document on the subject of gaining early clinical experience under its Investigational Device Exemption(IDE) rules.  This guidance, when finalized, will represent the FDA’s current thinking on the topic of IDEs for devices  in order to provide early clinical evaluation to provide proof of principle and initial clinical safety data.

An excerpt from the document states: Studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. However, as with all clinical studies, initiation of an early feasibility study must be justified by an appropriate risk-benefit analysis and adequate human subject protection measures.

For the purposes of this guidance, clinical study types are defined as follows:

  • An early feasibility study is a limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). It may be used to evaluate the device design concept with respect to basic safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot be readily provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications. An early feasibility study does not necessarily involve the first clinical use of a device.
  • first in human (FIH)study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. This document only discusses FIH studies that meet the definition of an early feasibility study.
  • traditional feasibility study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. As compared to an early feasibility study, more nonclinical (or prior clinical) data are necessary for approval to initiate a traditional feasibility study2; however, a traditional feasibility study does not necessarily need to be preceded by an early feasibility study.
  • pivotal study is a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.

In its overview FDA states that: FDA recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective, or associated with substantial risks to patient safety. This guidance has been developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies.

The full document can be found here.

Source: FDA, medlatest staff