In Response to MDUFA Commitments, FDA Prepares to Make Changes to IDE Submission System
Medical device regulators at the US Food and Drug Administration (FDA) are planning to unveil a new technology platform in August 2013 through which industry will be expected to submit clinical trial requests, the agency announced today.
The change is occurring as a result of FDA's commitments to industry under the Medical Device User Fee Act of 2012, a subset of the Food and Drug Administration Safety and Innovation Act (FDASIA). As outlined in a commitment letter accompanying that legislation, FDA committed to better tracking the milestones of submitted applications, including investigational device exemption (IDE) and emergency use authorization (EUA) applications used to commence clinical testing of a product.
Presently, the system used to track these milestones is not able to meet FDA's commitments under the law, and so on 18 August 2013, FDA will change over to a new system capable of doing so.
"The changes will provide a mechanism for tracking multiple studies-such as feasibility or pivotal studies-under a single original IDE submission number," FDA explained in an email to its industry mailing list. "Each subsequent submission to an IDE will be assigned to the appropriate study, so that the FDA can track milestones in clinical trial development, IDE approval, study initiation, and study completion."
Industry will see changes in two primary ways, the agency continued. Prior to the changes, changes to an IDE would be filed as either supplements or amendments. However, under the new system, FDA plans to consider reports to be a separate subtype, and not a supplement. In addition, a deficiency letter will also not be considered a supplement for the purposes of tracking. "Instead, FDA will track deficiency letter responses as Amendments to the original IDE, IDE Supplement or IDE Report for which we issued the deficiency letter," FDA explained.
New Submission Types | ||
Supplements | Reports | Amendments |
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In addition, FDA added that each IDE submission should "address only one submission reason" to avoid a submission that meets multiple criteria.
"FDA recommends that sponsors not include multiple requests or combine a change request with a deficiency letter response or report within a given submission," it wrote. "During a three month transition period, FDA will work interactively with submitters to address any submissions that mistakenly contain multiple submission reasons, such as those described in the examples above."