Expanded Regulatory Criteria for When Can Number of FDA How is FDA Patient Protection Access Authority Use It Be Patients to be Approval Approval Measures Mechanism Used? Treated Needed? Obtained? Emergency "Guidance for 1. Before or Limited to few No; Not applicable 1. Independent Use the after patients submit assessment by Emergency initiation of report to uninvolved condition‡; Use of 2. No clinical trial FDA doctor; Unapproved alternative; following 2. IRB Medical and device chairperson's Devices" 3. No time to use concurrence; obtain 3. Institutional FDA approval. clearance; and 50 FR 42866 4. Informed 21 CFR consent 812.35(a) Compassionate 21 CFR 1. Serious During Individual Yes IDE supplement 1. Independent Use 812.35(a) disease clinical trial patient or small with: assessment by or condition groups of 1. Explanation of uninvolved and patients circumstances doctor; 2. No constituting need 2. IRB alternative. for chairperson's the device; concurrence; 2. Reasons 3. Institutional alternatives not clearance; and acceptable; 4. Informed 3. Deviations from consent. protocol, if any; and 4. Patient protection measures. Treatment IDE 21 CFR 1. During Wide access; Yes Trt IDE 1. IRB approval 812.36 clinical trial depends on supplement with: and or serious patient/physician 1. Intended Use, 2. Informed disease; need protocol, consent. 2. No and patient alternative; selection 3. Controlled criteria; clinical trial; 2. Rationale for trt and use 4. Sponsor 3. Methods used to
Expanded Access Mechanism Regulatory Authority Criteria for Use When Can It Be Used? Number of Patients to be Treated FDA Approval Needed? How is FDA Approval Obtained? Patient Protection Measures Emergency Use "Guidance for the Emergency Use of Unapproved Medical Devices" 50 FR 42866 21 CFR 812.35(a) 1. condition‡; 2. No alternative; and 3. No time to obtain FDA approval. Before or after initiation of clinical trial Limited to few patients No; submit report to FDA following device use Not applicable 1. Independent assessment by uninvolved doctor; 2. IRB chairperson's concurrence; 3. Institutional clearance; and 4. Informed consent Compassionate Use 21 CFR 812.35(a) 1. Serious disease or condition and 2. No alternative. During clinical trial Individual patient or small groups of patients Yes IDE supplement with: 1. Explanation of circumstances constituting need for the device; 2. Reasons alternatives not acceptable; 3. Deviations from protocol, if any; and 4. Patient protection measures. 1. Independent assessment by uninvolved doctor; 2. IRB chairperson's concurrence; 3. Institutional clearance; and 4. Informed consent. Treatment IDE 21 CFR 812.36 1. or serious disease; 2. No alternative; 3. Controlled clinical trial; and 4. Sponsor During clinical trial Wide access; depends on patient/physician need Yes Trt IDE supplement with: 1. Intended Use, protocol, and patient selection criteria; 2. Rationale for trt use 3. Methods used to 1. IRB approval and 2. Informed consent.
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