Can an unapproved or uncleared investigational IVD device ever be used for non-emergency treatment of patients who do not meet the inclusion criteria of an investigational study?
Yes, in exceptional situations. CDRH recognizes that there are circumstances when an unapproved or uncleared IVD is the only available option for a patient or small group of patients who do not meet the inclusion criteria and “compassionate use” of the device may be appropriate. Federal Food, Drug, and Cosmetic Act, Section 561. CBER has a similar program termed “single patient exemption.” FDA requires for compassionate use the same patient protection measures required for emergency use, noted above. Use of an investigational IVD device for one or a small group of patients who do not meet the study inclusion criteria would require a change to the investigational plan. If the study is being conducted under an approved IDE, the sponsor should submit a supplement to the IDE requesting a change to the investigational plan for “compassionate use”. 21 CFR 812.35(a). The review of this supplement can be facilitated by a phone call to the reviewing division and by the submission by facsimile o
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