Committee For the Protection of Human Subjects

Humanitarian Use Device (HUD)

POLICY

It is the policy of UTHSC-H that CPHS approval shall be obtained prior to use of an HUD.  A request to use an HUD shall be reviewed and approved at a full board meeting, however, subsequent continuing review may be conducted by expedited procedures, unless CPHS determines that full board review should be performed.

 

Key Terms

Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

A Humanitarian Device Exemption (HDE) is an application for FDA approval for marketing an HUD. An HDE authorizes the applicant to market the device and healthcare providers to use the device.

 

PROCEDURE

Submission: The physician should submit a CPHS application via iRIS and a letter from the sponsor which contains the following supplemental information:

a.          The generic and trade name of the device;

b.         The FDA HDE number;

c.          The date of HUD designation;

d.         The indications for use of the device;

e.         A description of the device;

f.           Contraindications, warnings, and precautions for use of the device;

g.          Adverse effects of the device on health;

h.         Alternative practices and procedures;

i.            Marketing history; and

j.           A summary of studies using the device.

 

Review – ORSC Staff will assign a request for use of HUD for review at a full board meeting. The subcommittee will verify that the documents provided are consistent with the manufacturing labeling and the approved use under the HDE.

Although informed consent is not required by the HUD regulations unless the HUD is being used under a research protocol, CPHS may require prospective informed consent. If available, patient labeling that incorporates information to assist a patient in making an informed decision about the use of the HUD may be used instead of consent document. The consent document or patient labeling should state that the device is a humanitarian use device and effectiveness for the labeled indication has not been demonstrated.

CPHS may approve use of an HUD for a period of one year or less. CPHS may in certain circumstances require review and approval of individual uses of a HUD. CPHS may approve use of the HUD, for instance, without any further restrictions, under a protocol, or on a case-by-case basis.

 

Reporting: Whenever the physician receives or otherwise becomes aware of information, from any source, that reasonably suggests that a HUD has or may have caused or contributed to the death or serious injury of a patient, the physician must report such findings to the FDA and CPHS as soon as possible, but no later than 10 working days after the Investigator first learns of the effect or problem as per policy and procedure on reporting unanticipated problems. This reporting is in addition to, not a substitute for, FDA and/or manufacturer reporting requirements in accordance with 21 CFR 803.30. The physician or health care provider must promptly report any FDA action(s) regarding the HUD to the IRB. Modifications to the HUD or the clinical use of the HUD are to be promptly reported to CPHS in accordance with policy and procedure on Change Requests and Protocol Amendments.

 

Emergency Use - In an emergency situation, a HUD may be used off-label to save the life or protect the physical well-being of a patient; however, in this situation, the physician and HDE holder must follow the same emergency use procedures described in policy and procedure of Emergency Use of Unapproved Medical Device. Briefly, in such an emergency situation, the physician shall, within 5 days after the use of the device, provide written notification to the chairman of the CPHS of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

 

APPLICABLE REGULATIONS

1.       21 CFR 814 Subpart H--Humanitarian Use Devices.

REFERENCE TO OTHER POLICIES 

1.       Unanticipated Problems Involving Risks to Subjects or Others

2.       Emergency Use of Investigational Drug or Device

3.       Change Requests and Amendments

ATTACHMENTS

1.       Initial Review Panel – Humanitarian Use Device

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

 

Document Number:

101-D03

Document Name:

Humanitarian Use Device

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011

 


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Committee for the Protection of Human Subjects
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