Table 3.

The FDA's expanded access mechanism for devices.

Category	Emergency Use	Compassionate Use (Individual Patient Access)	Treatment IDE	Continued Access
Regulation	21 CFR 812.35(a) “Guidance for the Emergency Use of Unapproved Medical Devices” 50 FR 42866	21 CFR 812.35(a)	21 CFR 812.36 62 FR 48940	IDE Memorandum #D96-1
Safety reporting regulation	21 CFR 812.150	21 CFR 812.150	21 CFR 812.150	21 CFR 812.150
Criteria	1)Life-threatening or serious disease or condition. 2)No alternative. 3)No time to obtain FDA approval.	1)Serious disease or condition. 2)No alternative.	1)Life-threatening or serious disease. 2)No alternative. 3)Controlled clinical trial. 4)Sponsor pursuing marketing approval.	1)Public health need or preliminary evidence that the device will be effective and there are no significant safety concerns.
Population	Limited to few patients	Individual patient or small groups of patients	Wide access; depends on patient/physician need	The same patient population as pivotal trial
When can it be used	Before or after initiation of clinical trial	During clinical trial	During clinical trial or all clinical trials are complete	After completion of clinical trial
Prior the FDA approval	Not required (it shall be reported to FDA within 5-working days)	Required	Required	Required
Charge	Patienta or donation by company	Patient or donation by company	Patient or donation by company	Patient or donation by company
Example of products (ClinicalTrials.gov identifier)	AMPLATZER™ Muscular VSD Occluder (NCT00590382)	AMPLATZER™ Muscular VSD Occluder (NCT00590382)	DERMAGRAFT® (not applicable)	EXCOR® Pediatric Ventricular Assist Device (NCT01242891)
Example of products of which data from compassionate use cases are employed in approval review reports (premarket approval number or humanitarian device exemption number)	•Relay® Thoracic Stent-Graft with Plus Delivery System (P110038). •Syncardia temporary CardioWest™ Total Artificial Heart (TAH-t) (P030011). •EXCOR® Pediatric Ventricular Assist Device (H100004).

The US: The United States, CFR: Code of Federal Regulation, FDA: Food and Drug Administration, IDE: Investigational Device Exemptions.

Source: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126427.htm.

Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm.

Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080202.htm#III.

Source: Guidance on IDE Policies and Procedures.

ClinicalTrials.gov by the U.S. National Institutes of Health https://clinicaltrials.gov/.

DERMAGRAFT^® Treatment IDE source: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000036b.pdf.

Relay^® Thoracic Stent-Graft with Plus Delivery System (P110038) source: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110038b.pdf.

Syncardia temporary CardioWest™ Total Artificial Heart (TAH-t) (P030011) source: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf.

EXCOR^® Pediatric Ventricular Assist Device (H100004) source: http://www.accessdata.fda.gov/cdrh_docs/pdf10/H100004b.pdf.

Barostim neo^® Legacy System (H130007) source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/H130007b.pdf.

^aThe charge should not exceed an amount necessary to recover the costs of manufacture, research, development, and handling of the investigational device [21 CFR 812.7(b)].