Humanitarian Use Device

 

VIII.04

 

 

Humanitarian Use Device

 

 

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Objective

It is the policy of The University of Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human Subjects (CPHS) to review and approve the use of all Humanitarian Use Devices (HUD). This Policy/Procedure describes the review, approval and continuing approval of a Humanitarian Use Device (HUD) at UTHSC-H.

 

Policy/Procedure

I.              In order for a HUD to be used in treatment, diagnosis or research at UTHSC-H or those institutions for which it is the IRB of record, the CPHS must approve the use of the HUD for which a Humanitarian Device Exemption (HDE) has been issued.

 

A.     The CPHS approval must verify that the use of the HUD, as proposed, is in accord with current labeling of the device and does not exceed the scope of the FDA - approved indication

 

B.     The CPHS may impose more rigid restrictions for use of the HUD as a means of additional protections, should it feel it is necessary.

 

C.     The CPHS does not have to review and approve individual uses of a HUD, as long as the HUD is within the FDA - approved indication. The CPHS may approve use of the HUD without any further restrictions, use of the device under a protocol, or use of the device on a case-by case basis.

 

D.     HUDs may be used off-label in an emergency situation to save the life or protect the physical well-being of a patient, but the physician should follow the emergency use procedures governing such use of unapproved devices (Policy and Procedure 10).

 

II.           The initial review of a HUD shall occur at a full CPHS convened meeting. At the time of the initial review the CPHS may make the determination that subsequent reviews qualify for expedited review since use of a HUD within its approved labeling does not constitute research.

 

III.         The physician utilizing the HUD for treatment, diagnosis or research must use the HUD only in accordance with the labeling of the device, intended purpose, and in the designated population for which the FDA approved its use.

 

IV.        The Federal Food, Drug, and Cosmetic Act and the HDE regulation do not require informed consent because an HUD provides for marketing approval, and so use of the HUD does not constitute research or an investigation which would normally require informed consent. However, CPHS can require the use of an informed consent document and process at its discretion.

 

A.     The CPHS shall review any patient information that may assist a patient in making an informed decision about the use of the device. 

 

B.     If the HUD is the subject of a clinical investigation, routine CPHS approval and informed consent are required.

 

V.           Medical device reports submitted by the holder of the Humanitarian Device Exemption (HDE) to the Food and Drug Administration (FDA) in compliance with the requirements of 21CFR 803 shall be submitted to the CPHS for review by the subcommittee and shall be processed as are DSMB reports.

 

VI.        Reporting

 

A.     Should the physician receive or otherwise become 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 CPHS and FDA as soon as possible, but no later than 10 working days after the physician learns of the problem. This reporting is in addition to, not a substitute for, FDA and/or manufacturer reporting requirements.

 

B.     The physician shall promptly report any FDA action(s) regarding the HUD to CPHS.

 

C.     The physician must report each HUD use to the FDA.

 

 

Applicable Regulations and Guidelines

21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html )

21CFR 56( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

21CFR 803 ( http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr803_05.html )

21CFR 814 ( http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr814_05.html )

38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html )

45CFR 46.103(b)(5) ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

ICH E6 ( http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB )

Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry ( http://www.fda.gov/cdrh/ode/guidance/1381.html )

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Updated 5/2007, Report broken links