When is emergency use of unapproved devices acceptable? The Federal Regulations explicitly state how an unapproved device should be used in an emergency situation by a physician. The FDA website also provides a training presentation on this topic.
What is an emergency situation?
- All conditions must be met:
- Life-threatening disease or serious condition requiring immediate use
- No generally accepted alternative for treating the condition is available
- There is no time to use existing procedures to obtain FDA approval of an IDE
What are the responsibilities of the Physician prior to emergency use?
- In addition to meeting the criteria for an emergency situation, the following must be done by the physician:
- Assessment of potential benefit
- Institutional clearance per institution policy
- IRB chairperson concurrence
- Authorization from the Sponsor (if an IDE exists)
- Independent assessment by a physician not participating in the investigation (21 CFR 50.23)
- Obtain informed consent from patient or LAR (does not have to follow 21 CFR 50.25)
- If informed consent is not possible, the physician and a physician who is not participating in the investigation must certify in writing ALL of the following
- Life-threatening situation requiring immediate use of product
• No alternative for treatment
- Of note, there will be times where IRB and Sponsor approval are not able to be obtained prior to the procedure. Example: middle of the night or weekend case. In this case, these entities will need to be notified after the emergency use. (21 CFR 812.150 a 4)
What are the responsibilities of the Physician after emergency use?
- If an IDE exists, notify the Sponsor. The Sponsor must then notify the FDA (21 CFR 812.35 a 2)
- If an IDE does not exist, the Physician must notify the FDA
- Written summary of emergency use
- Patient protection measures
- Any scientific results
- Report to the IRB within five working days (21 CFR 56.104 c)
- Subsequent emergency use would need an IDE
If you need to use an unapproved device in an emergency situation, it would be important to follow the steps detailed above. In addition to these regulations, your Institution or IRB may have their own set of requirements to follow.
Have you worked with a site that used a device in an emergency situation before? How did you ensure the proper actions were carried out? Please share your experiences with us.
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