6. HUDs, Expanded Access, and Emergency Use: FDA's Special Pathways
After this lesson you can
- Explain the Humanitarian Use Device designation and the IRB's role in HDE use
- Distinguish the expanded access categories in 21 CFR 312 Subpart I
- Apply the emergency use exemption from IRB review and the emergency exception from consent at 50.23
- Apply the exception from consent for emergency research at 50.24, including community consultation and public disclosure
- Distinguish treatment use from research use of investigational products
Video coming soon
Scheduled for release on September 18, 2026.
HUDs, Expanded Access, and Emergency Use: FDA Special Pathways sorts out the four FDA provisions that can apply when a patient needs an unapproved product. Each one has its own conditions, its own clock, and its own role for the IRB, and this lesson separates them clearly.
5 Key Facts from This Lesson
- The Humanitarian Use Device threshold has been 8,000 patients per year since the 21st Century Cures Act of 2016, up from 4,000.
- Emergency use of a test article is exempt from prior IRB review under 21 CFR 56.104(c), but it must be reported to the IRB within five working days.
- The exception from informed consent for a single emergency use is a separate provision, 21 CFR 50.23, with its own independent physician review.
- 21 CFR 50.24 covers planned emergency research with an exception from consent and requires community consultation and public disclosure.
- Expanded access is treatment use, not research, yet it still requires an IND and IRB oversight; non-emergency requests wait 30 days after FDA receives the submission.
Exam traps
The distinctions exam questions on this topic are most often built to test. Know them cold.
The HUD threshold is 8,000 per year since 2016, not 4,000
The emergency use exemption at 56.104(c) is from prior IRB review; the consent exception is 50.23; they are separate
Five working days appears twice: the emergency use report to the IRB, and the 50.23 independent physician certification
50.24 is planned research with a consent exception; 50.23 is a one-off emergency; the exam swaps them
Expanded access is treatment, not research, yet still requires an IND and IRB oversight
Practice quiz
- Question 1A Humanitarian Use Device is intended for a condition affecting no more than how many people in the United States per year?
- Question 2Emergency use of a test article must be reported to the IRB within:
- Question 3Which provision allows planned research in emergency settings without prospective consent?
- Question 4Community consultation and public disclosure are requirements of:
- Question 5Expanded access to an investigational drug is intended primarily for:
Recap
- HUD designation at 8,000 patients; HDE approval on probable benefit; IRB approves facility use under 814.124
- Expanded access: treatment for serious conditions with no alternative, three categories, IND required, IRB review with chair concurrence for individuals
- Emergency use: life-threatening, no standard treatment, no time; report to the IRB within five working days; 50.23 excepts consent with independent physician certification
- 50.24: planned emergency research with consent excepted, community consultation, public disclosure, therapeutic window, data monitoring committee
- Treatment use versus research use is the line through all four
Coming next
Lesson 7, Agency Differences.
Saved in your browser only: no account, no server.
This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.