New Guidance Offers Clarification on IDE Requirements
School bells are sounding the death knell of summer across the land. But, as we’ve noted before, the FDA didn’t take much time off to enjoy surf and sand.
The agency capped a busy season last week by issuing a new guidance aimed at Investigational Review Boards, Clinical Investigators, and Sponsors when determining if an Investigational Device Application (IDE) or an Investigational New Drug Applications (IND) is warranted.
Structured in a helpful Q&A format, the guidance should make it easier for device and drug companies and other entities to understand what’s expected of them in this often gray area.
For example, the guidance reaffirms that an IRB must review the qualifications of clinical investigators who conduct FDA-regulated research.
However, the agency does illustrate some situations where there is interpretive leeway for regulated entities. “In many cases, the IRB may have previous experience with an investigator or institution that would allow the IRB to readily determine that the clinical investigator is appropriately qualified to conduct and supervise the proposed research.” If that’s the case, you’re probably okay to get started.
The guidance also reminds us clinical investigator report cards are available on the FDA website. IRBs may check the lists posted on FDA’s website to determine whether a clinical investigator has been the subject of an inspection by the agency and the results of such inspections (e.g.,Warning Letters). FDA also posts on its website a listing of all investigators who have been notified of the initiation of a disqualification proceeding or have been disqualified.
The guidance also spells out the requirements to determine whether submission of an IDE application to FDA is required. That determination is based, in part, on assessing the risk factor for the device. The IDE regulations (21 CFR 812) describe three types of device studies: significant risk (SR), nonsignificant risk (NSR).
The sponsor is responsible for making the initial risk determination, and presenting it to the IRB. If the sponsor has determined that a device study is NSR, the IRB must review the sponsor’s determination. If the IRB disagrees with the sponsor’s NSR assessment and decides the study is SR, the IRB must inform the clinical investigator and, where appropriate, the sponsor. The IRB should also document its SR/NSR determination in the IRB meeting minutes.
FDA can assist sponsors, investigators, and IRBs in making the determinations. Information on how to get started can be found in the agency’s 2011 guidance Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices.
FDA’s lists of investigators it has examined can be found here: