The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).
"A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can ensure appropriate patient and participant protections in investigational research settings," FDA writes.
In general, FDA explains that its expectations for mitigating risks will vary throughout the product development lifecycle, scaling from an expectation that sponsors will include risk mitigation measures for anticipated possible risks and unanticipated risks earlier on in development, and mitigation measures aimed at addressing probable risks later on.
Changes From the Draft Guidance
While the overall content and structure of the guidance are largely retained in the final guidance, FDA has made a number of changes to the draft version issued in June 2015.
One of the biggest changes to the final guidance involves the discussion focused on "well-designed studies."
In its comments on the draft version, the Advanced Medical Technology Association (AdvaMed) protested the numerous references to well-designed studies, arguing that the use of the term could lead to "inconsistent FDA reviews" where IDEs are disapproved based on the reviewer's interpretation of a well-designed study.
According to AdvaMed, these references to well-designed studies are contrary to Section 520(g) of the Food, Drug, and Cosmetic Act, as amended by the 2012 Food and Drug Administration Safety and Innovation Act, which prohibits FDA from rejecting an IDE because the study plan may not support approval or clearance of a marketing application.
While the final guidance retains a number of references to well-designed studies, including a statement that "well-designed studies are more likely to produce important knowledge about a device or disease," the agency has added a statement to the section on Study Design Considerations clarifying that it will not disapprove an IDE for these reasons.
The final version also clarifies that the scope of the guidance applies to original IDE applications, IDE amendments and IDE supplements, whereas the draft version only referred to IDEs generally.