Yes, in exceptional situations. FDA 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”/single patient use of the device may be appropriate. Section 561 of the Act.
CBER refers to such situations as “single patient exemptions.” Appropriate
patient protection measures are needed for these studies.
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. 21 CFR 812.35(a). 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 of an advanced copy of the supplement. If the
investigational IVD device would require an FDA-approved IDE, but one has not
yet been submitted or approved, FDA intends to exercise enforcement discretion
where the sponsor submits a compassionate use request to CDRH or CBER, as
appropriate, and follows the patient protection measures listed above for
emergency use.4
If a study is being conducted according to an exemption under 21 CFR
812.2(c)(3), or as a non-significant risk IDE under 21 CFR 812.2(b), the sponsor
should obtain prior approval for the specific compassionate use/single patient use
for the individual(s) in question from the FDA and the reviewing IRB at the site
where the physician proposes to use the device.
