Table 2.

FDA Pathways for Use of Unapproved Medical Devices^∗

EA Pathway	Criteria for Use	When Can It Be Used?	No. of Patients to Be Treated	FDA Approval Needed?	How Is FDA Approval Obtained	Patient Protection Measures
Emergency use	•Life-threatening condition •No alternative •No time to obtain FDA approval	Before or after initiation of clinical trials	Individual or few patients	No: submit report to FDA within 5 days after treatment	N/A	•Independent assessment by uninvolved physician •IRB chairperson’s approval •Institutional approval •Informed consent
Compassionate use	•Serious disease or condition •No alternative	While clinical trials are ongoing	Individual patient or small patient groups	Yes	IDE supplement including: 1)Explanation of the circumstances of need 2)Reasons existing alternatives are not acceptable 3)Description of deviations from trial protocols 4)Patient protection measures to be taken	•Independent assessment by uninvolved physician •IRB chairperson’s approval •Institutional approval •Informed consent
Treatment IDE	•Life threatening or serious disease or condition •No alternative •Controlled clinical trial •Sponsor is pursuing marketing approval	During (within) a clinical trial	Wide access depending on patient/physician need	Yes	Treatment IDE supplement, including: 1)Intended use, protocol, patient selection criteria 2)Rationale for treatment use 3)Methods to evaluate device use and minimize risks 4)Monitoring plan 5)Summary	•IRB approval •Informed consent
Continued access: patients are allowed continued access to a investigational device during pre-marketing application and review	•Public health need or preliminary evidence that device will be effective and no significant safety concerns	After completion of a clinical trial	Same rate of enrollment as for study	Yes	IDE supplement, including: 1)Justification for extended use 2)Summary of safety and efficacy data and risks posed by the device 3)Clinical protocol 4)Progress toward marketing approval	•IRB approval •Informed consent

EA = expanded access; FDA = U.S. Food and Drug Administration; IDE = investigational device exemption; IRB = institutional review board.

^∗See reference (5).

Adapted from Guidance on IDE Policies and Procedures. U.S. Food and Drug Administration (3).