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
- Change in correspondent, manufacturer, or sponsor
- Change in design or manufacturing
- Change in informed consent or protocol
- 5-day notices
- Request for compassionate use, live case demonstration, or other deviation from approved protocol
- Expansion of study (patients and/or sites)
- Extension of time to respond to FDA letter
- Request for waiver
- Institutional Review Board (IRB)certification
- Request for Centers for Medicare and Medicaid Services (CMS) recategorization
- Notification of study suspended or resumed
- Acknowledgement and response to clinical hold
- Termination of study without final report
- New study or protocol
- Adverse Effect
- Final, Study Completed
- Annual Progress
- Interim Progress
- Semiannual Investigator List
- Failure to Obtain Informed Consent
- Compassionate Use Follow-Up
- Emergency Use
- Live Case Follow-Up
- Response to Disapproval
- Response to Approval with Conditions
- Response to Refuse to Accept
- Response to Report Deficient
- Voluntary Withdrawal by Sponsor
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."
FDA Statement on IDE/EUA Changes