To: Chairs, Institutional Review Boards (IRBs)
Subject: IRB Review of Post-Approval Studies of Medical Devices
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) is issuing this letter to Institutional Review Boards (IRBs) to provide important information regarding post-approval studies of medical devices.
CDRH approves medical devices for marketing. Occasionally, CDRH requires device manufacturers to conduct post-approval studies to help monitor the safety, effectiveness and reliability of a device for its intended use. These studies are conducted under an FDA-approved protocol with the intended purpose of gathering specific additional information about the marketed device. Timely enrollment of patients for these post-approval studies, particularly in the case of breakthrough technologies for which the agency expects to have rapid and widespread dissemination, is very important. CDRH expects that manufacturers will initiate required post-approval device studies as soon as possible to collect the earliest information possible as the device is incorporated into medical practice. CDRH also expects that most protocols for post-approval studies will be finalized and agreed upon prior to a device's approval for marketing.
Some post-approval device studies will involve continued, long-term follow-up of study subjects included in the pre-market clinical trials (i.e., the original study cohort). For such studies, FDA may already have advised the sponsors to obtain IRB approval for long-term follow-up at the outset of the original clinical study, because seeking IRB approval after the device is approved for marketing will delay timely follow-up of study subjects. If IRB approval was not obtained for this long-term follow-up when the original study was reviewed by the IRB, you will be asked to review the post-approval study even though it involves the continued evaluation of the original patient cohort.
Some post approval device studies will require recruitment of a new cohort of patients to address FDA's request to continue reporting safety, effectiveness and reliability information of the device (e.g. all uses of the marketed device, unanticipated adverse events, or device experience in certain vulnerable populations, etc.).
Many post-approval studies are conducted at multiple sites. Institutions may consider use of a central IRB review process given that “institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort” (21 CFR 56.114, Cooperative Research). Therefore, when offered the opportunity and when practicable, we encourage your consideration of working with a central IRB for these post approval device studies.
Protocol review and approval by the IRB is an essential step in initiating any clinical study. To assure continued safety, effectiveness and reliability of marketed medical devices, CDRH believes that IRB review of post-approval protocols should be carried out as expeditiously as possible, so that patient enrollment may begin as quickly as possible following device approval.
It is important to review protocols as soon as they are available and not wait until the device receives FDA approval for marketing before the review process begins. The earlier the IRB approval, the earlier the study sites can be readied to collect the postmarket experience with the new device.
We sincerely appreciate your continued support in assisting FDA to promote and protect public health by ensuring the safety and effectiveness of marketed devices for all Americans.
Daniel G. Schultz, M.D.
Center for Devices and Radiological Health