Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions. While that post focused on FDA’s IDE decision-making process and the regulatory implications of those decisions, this post addresses a new program within CDRH—the Pre-Decisional IDE program—that FDA proposed in the draft guidance.
To further help applicants reach their goal of device clearance or approval, FDA proposed the Pre-Decisional IDE process. According to FDA, the Pre-Decisional IDE process is “a voluntary approach to enable sponsors to obtain timely feedback from review staff on a near-final IDE application, with the opportunity for a mid-cycle interaction with the review team to promote a clearer understanding and quicker resolution of major issues with device or subject safety as well as study design.” In contrast to the Pre-Submission (formerly Pre-IDE) process, “Pre-Decisional IDEs will include data and full study protocols and reports where appropriate, and will be reviewed in a similar manner as an IDE, allowing for more complete and meaningful feedback from review staff.”
The Pre-Decisional IDE process involves:
Submission: The applicant submits an application that is clearly marked “Pre-Decisional IDE” with potential dates for the applicant to receive mid-cycle feedback. The Report of Prior Investigations should include a strategy for addressing the investigational device’s risks and identify the benefit for the target patient population.
Application Screening: Within five calendar days of receipt, FDA will determine whether the application is sufficiently complete and eligible for substantive review. If the application is deemed inadequate, the applicant will have an opportunity to convert the application to a Pre-Submission or to withdraw the Pre-Decisional IDE and resubmit with the missing information.
Substantive Review with Mid-Cycle Interaction: After FDA accepts the Pre-Decisional IDE application for review, a 30-day review period commences. At the end of the review period, FDA should notify the applicant of any concerns that—if the application were an IDE—would result in disapproval, be a condition of approval, and/or constitute study design considerations that would not support market approval or clearance.
Within 15 days after the close of the 30-day review period, or at a mutually agreed-upon time, FDA and the applicant should confer on the Pre-Decisional IDE application and FDA’s initial feedback. Following the meeting, the applicant may request (within seven days) that the Pre-Decisional IDE be converted to an IDE. FDA “intends” to issue a decision letter within 15 days of the request; however, if the applicant provides new information as part of the request, a 30-day review period will commence.
Absent such a conversion request, FDA should provide complete written feedback within 15 days of the meeting. The applicant may then: (1) submit a formal IDE application; (2) submit a response and request additional feedback; or (3) submit a response and request to repeat the Pre-Decisional IDE process.
While the opportunity to have more interaction and dialogue with FDA on study design considerations could be appealing to applicants, it is unclear whether this voluntary program will have the intended effect of promoting timely initiation of clinical investigations, or whether this new program will become an additional step applicants must go through to obtain an approved IDE. For certain applicants, however, the program would appear to provide a useful alternative to submitting either a Pre-Submission or an IDE.