s**********8
发帖数: 25265 | 1 DEFINITIONS:
I. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit
patients
by treating or diagnosing a disease or condition that affects fewer than 4,
000
individuals in the United States per year.
II. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
(FDA) approval of an HDE permits the marketing of an HUD, subject to
restrictions
on charges and use. Specifically, HUDs cannot be sold for profit, except in
the
limited circumstance when indicated for use in children, and can only be
administered in facilities after IRB approval is obtained, except in certain
emergencies. Approval of an HDE requires evidence of safety and probable
benefit
but does not require establishing effectiveness.
POLICY:
I. In order for a HUD to be used in treatment or diagnosis at UIC or JBVAMC,
the HUD
must have an approved HDE from the FDA and IRB approval. FDA regulations and
UIC HSPP require initial IRB review and approval at a convened meeting.
Emergency and compassionate use of a HUD may be allowed in accordance with
FDA regulations and HSPP policy.
II. Informed consent is not required by FDA regulations when a HUD is used
for an
approved indication, unless the use represents a clinical investigation.
However, the
IRBs generally invoke their regulatory discretion in this circumstance and
require documented informed consent. In lieu of the HUD informed consent
template, health care practitioner (investigator) may request the use of an
alternative
format, e.g., substitution of the FDA approved patient information packet
for some of
the required sections of the HUD consent template.
III. Collection of safety and effectiveness data to support a premarket
approval (PMA)
application by the HDE- holder for the HDE-approved indication may occur
under the
HDE without the need to obtain an Investigational Device Exemption (IDE).
However, the activity is considered a clinical investigation (i.e., research
) rather than
clinical practice and, as with other FDA-regulated clinical studies, IRB
approval and
informed consent are required. Also, since the activity is now considered
research,
authorization from the patient (or waiver of authorization) under the HIPAA
Privacy
Rule is required for protected health information to be used or disclosed.
Humanitarian Use Devices (HUD), Version 1.0
Page 2 of 5 OVCR Document #0922
PROCEDURE:
I. The health care practitioner (investigator) is required to submit the
following
materials to the IRB for review and approval of the use of a HUD:
A. HUD application;
B. FDA HDE approval order (a list of approved HDEs along with the approval
order, summary of safety and probably benefit, labeling and patient
information is available at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInfo
m#2 );
C. Professional labeling;
D. Summary of safety and probable benefit;
E. Device manual or brochure (if available);
F. Patient labeling/Information Packet (if available);
G. Protocol (if available);
H. Consent form for use of the HUD.
The entire board receives copies of items A, F and H, while all items are
provided
to the primary reviewers. All IRB members have access to the complete
protocol
file, containing items A through H.
II. Consent for Clinical Use of the HUD.
A. Informed consent and documentation of informed consent is required when
treating or diagnosing a patient with a HUD.
B. The format, required sections and recommended language for the HUD
consent for clinical use are provided on the UIC HUD consent template.
C. When FDA-approved patient information labeling or packet is available,
this
document may substitute for certain required sections of the consent,
including “Why does my doctor want to use this …”, “What will be
involved
with use of the HUD”, “Risks”, “Benefits”, and “Alternative.”
III. When available, any FDA-approved patient labeling information prepared
by the
manufacturer is to be provided and reviewed with the patient prior to use of
the HUD
regardless of whether it is being used as part of the consent process. The
plan for
how this will be conducted is to be described in the HUD application.
IV. Initial IRB Review of a HUD.
A. Initial review of a HUD is performed at a convened meeting of the IRB.
B. IRB reviews the material listed in I. in making their determination.
C. IRB review and approval of the HUD request follows the review criteria at
21
CFR 56.111 as much as possible, including:
1. Evaluating the risks described in the product labeling and ensuring the
risks are minimized,
2. Ensuring risks are reasonable in relation to the anticipated benefits of
the proposed use of the device,
Page 3 of 5 OVCR Document #0922
3. Ensuring informed consent is obtained from each prospective patient or
their legally authorized representative,
4. Ensuring informed consent is appropriately documented, and
5. Where appropriate the plan for use of the HUD adequately monitors
the safety of subjects.
D. IRB must verify that proposed use of HUD corresponds with the current
labeling and does not exceed the scope of the FDA-approved indication.
E. The IRB evaluates whether the health care provider(s) is qualified
through
training and expertise to use the device.
F. The IRB may approve use of the HUD without any restrictions beyond the
FDA-approved labeling or may impose more stringent criteria for use of the
HUD as deemed necessary to provide additional protections.
G. IRB determines the continuing review frequency (i.e., at least annually)
and
whether it may occur by expedited procedures.
H. The IRB’s determination is documented in the meeting minutes.
I. Use of the HUD should be restricted to personnel listed on the HUD
application reviewed and approved by the IRB.
J. The HUD must be stored in a secure manner and labeled appropriately to
prevent the use by unapproved personnel or the use of the device in an
unapproved manner.
V. Continuing IRB Review of a HUD.
A. The IRB will conduct a continuing review of the use of the HUD at
intervals
appropriate to the degree of risk, but no less than once a year.
B. Continuing review may be performed by expedited procedures by the IRB
Chair or member designated by the Chair.
C. Continuing review of the HUD should follow UIC Continuing review policy.
HUD-specific information that should be provided the IRB reviewer includes:
1. Number of times the HUD has been used,
2. Any problems associated with its use,
3. Unanticipated problems, including serious adverse events and
deviations since the last review.
4. Any use outside of the FDA approved labeling or emergency use,
5. Any information provided to the sponsor or FDA concerning use at
Other sites or any annual reports to the FDA, and
6. Any Medical Device Reporting reports or UIC Prompt Reporting
reports.
VI. Modifications to the HUD or proposed changes to the clinical use of the
device must
be submitted for IRB review and approval using the UIC Amendment application.
The amendment application should be accompanied by 1). the FDA’s approval
of the
modification, 2). the HDE holder’s amendments to the HUD product labeling,
clinical
brochure, and/or other pertinent materials corresponding to the requested
modification(s), and 3). the revised clinical consent form with the
modifications
indicated. .
Page 4 of 5 OVCR Document #0922
VII. Collection of Safety and Effectiveness Data when HUD is used in
Accordance
with its Approved Indication(s).
A. Collection of safety and effectiveness data to support a PMA application
by
the HDE-holder for the HDE-approved indication may occur under the HDE
without the need to obtain an Investigational Device Exemption (IDE).
B. This activity is considered by the FDA to represent a clinical
investigation (i.e.,
research) and, as with other FDA-regulated clinical studies, IRB approval
and
informed consent are required.
C. The investigator should submit the materials described in I. for IRB
review and
approval.
D. The investigator must also complete and submit the additional sections on
the
HUD application and Consent Form designated for completion when safety
and effectiveness data are being collected for an FDA-regulated clinical
investigation or other research activity.
E. Also, since the activity is now considered research, authorization from
the
patient (or waiver of authorization) under the HIPAA Privacy Rule is
required
for protected health information to be used or disclosed. HIPAA
authorization
language is incorporated into the UIC HUD consent form.
F. Initial and continuing review by the IRB will follow the criteria in the
UIC Initial
and Continuing Review Biomedical Review Guide along with the criteria
outlined for the clinical use of a HUD in sections IV and V.
G. Even when the data will not be submitted to the FDA, the collection of
safety
and efficacy related to use of the HUD for its approved indication by the
investigator for activities meeting the OHRP or FDA definition of human
subject research (see UIC HSPP policy Institutional Authorization for
Determining whether Research or Other Activities Represent Human Subjects
Research) must follow the additional submission and review requirements
described here for those activities representing FDA-regulated studies.
VIII. Considerations for Prompt Reporting.
A. Whenever the physician or health care provider primarily responsible for
use
of the HUD at UIC becomes aware of information, from any source, that
reasonably suggest that a HUD has or may have caused or contributed to the
death or serious injury of a patient, the physician or health care provider
must
report such findings to the FDA and the UIC IRB as soon as possible, but no
later than 10 working days after the Investigator first learns of the effect
or
problem. The UIC Prompt Reporting Form should be used to submit this
information to the IRB.
B. The reporting requirements outlined in the UIC HSPP policy Unanticipated
Problems and Other Events Requiring Prompt Reporting, should be adhered
to with the use of the HUD.
C. The health care practitioner responsible for use of the HUD shall report
any
FDA actions regarding the HUD to the IRB within 10 working days of being
notified.
IX. Use of a HUD in an Emergency. The HUD may be used off-label (i.e., a
nonapproved
indication) or without prior IRB approval in an emergency situation. The
Humanitarian Use Devices (HUD), Version 1.0
Page 5 of 5 OVCR Document #0922
UIC Policy on “Emergency Use of Test Article” must be followed, including
obtaining
concurrence of the IRB chair or designee, informed consent from subject or
legally
authorized representative, independent assessment from a uninvolved
physician and
authorization from the HDE holder.
X. Compassionate Use of HUD. The FDA allows the use of a HUD in
circumstances
where the device is the only option available for a patient faced with a
serious or lifethreatening
condition that does not meet the criteria of an emergency. A use is
commonly referred to as “compassionate use”. Unlike emergency use, prior
FDA
approval is required before compassionate use occurs. As a first step, the
clinician
should seek the approval of the HDE holder and provide them with the
following
information: 1). description of the patient’s condition and circumstances
necessitating, 2). discussion of why alternative therapies are
unsatisfactory, an
identification of any deviations from the approved HUD labeling required to
treat the
patient and patient protection measures that will be followed. The HDE
holder must
then submit an IDE(HDE) supplement to the FDA for approval. Once FDA
approval
is obtained, the investigator should submit the materials listed in I. along
with
documentation of FDA approval of the compassionate use to the IRB for review
and
approval.
REFERENCES:
21 CFR 814 subpart H
21 CFR 803.30
21 CFR 814.124(a)
21 CFR 812.35
FDA Guidance: Draft Guidance for HDE Holders, IRBs, Clinical Investigators,
and FDA
Staff – HDE Exemption Regulation: Questions and Answers, dated August 5,
2008.
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/po | s**********8
发帖数: 25265 | 2 from a univ's website.
in
【在 s**********8 的大作中提到】
: DEFINITIONS:
: I. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit
: patients
: by treating or diagnosing a disease or condition that affects fewer than 4,
: 000
: individuals in the United States per year.
: II. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
: (FDA) approval of an HDE permits the marketing of an HUD, subject to
: restrictions
: on charges and use. Specifically, HUDs cannot be sold for profit, except in
| R**********s
发帖数: 4627 | | s**********8
发帖数: 25265 | 4 lol. 本来就不是好玩的版. 你来发些好玩的, 给额调节一下.
【在 R**********s 的大作中提到】
: 你这个版一点都不好玩
| h******e
发帖数: 1811 | 5 我觉得很好啊，可能是我这个人没趣，all work no play吧，还是希望自己保持这样，
多学点儿东西对己，对孩子的教育都有好处。我表姐的孩子要来美国上大学，让我给参
谋一下专业呢。
8挂不是有8挂的专门区域吗？除非是想把太尉拉过去吧？LOL
【在 s**********8 的大作中提到】
: lol. 本来就不是好玩的版. 你来发些好玩的, 给额调节一下.
| a********y
发帖数: 8573 | 6 谢谢兄弟
--太尉
【在 h******e 的大作中提到】
: 我觉得很好啊，可能是我这个人没趣，all work no play吧，还是希望自己保持这样，
: 多学点儿东西对己，对孩子的教育都有好处。我表姐的孩子要来美国上大学，让我给参
: 谋一下专业呢。
: 8挂不是有8挂的专门区域吗？除非是想把太尉拉过去吧？LOL
| s**********8
发帖数: 25265 | 7 就是, 色文额发文清, 不发这儿的.
【在 h******e 的大作中提到】
: 我觉得很好啊，可能是我这个人没趣，all work no play吧，还是希望自己保持这样，
: 多学点儿东西对己，对孩子的教育都有好处。我表姐的孩子要来美国上大学，让我给参
: 谋一下专业呢。
: 8挂不是有8挂的专门区域吗？除非是想把太尉拉过去吧？LOL
| s**********8
发帖数: 25265 | 8 .... naughty啊
【在 a********y 的大作中提到】
: 谢谢兄弟
: --太尉
| s**********8
发帖数: 25265 | 9 其实也可以发. TT也算器械吗?
【在 s**********8 的大作中提到】
: 就是, 色文额发文清, 不发这儿的.
| h******e
发帖数: 1811 | 10 99% safe rate, which pill can beat that?
LLLLLLOOOOOOOLLLLLLL!!!
【在 s**********8 的大作中提到】
: 其实也可以发. TT也算器械吗?
| | | s**********8
发帖数: 25265 | 11 higher than that bah. 要不私生子会很多.
simple math. 干二十次, 每次99%, 那么20%会种上. but not that high number. so.
...
【在 h******e 的大作中提到】
: 99% safe rate, which pill can beat that?
: LLLLLLOOOOOOOLLLLLLL!!!
| s**********8
发帖数: 25265 | 12 一说干, 在线人数彪升啊. 看来这是王道.
so.
【在 s**********8 的大作中提到】
: higher than that bah. 要不私生子会很多.
: simple math. 干二十次, 每次99%, 那么20%会种上. but not that high number. so.
: ...
| s**********8
发帖数: 25265 | 13 有两位不好意思走了
【在 s**********8 的大作中提到】
: 一说干, 在线人数彪升啊. 看来这是王道.
:
: so.
| S****u
发帖数: 3092 | 14 都版主了装得庄重些有那么难嘛
【在 s**********8 的大作中提到】
: 一说干, 在线人数彪升啊. 看来这是王道.
:
: so.
| a********y
发帖数: 8573 | 15 我们在认真记笔记
【在 s**********8 的大作中提到】
: 一说干, 在线人数彪升啊. 看来这是王道.
:
: so.
| h******e
发帖数: 1811 | 16 宾语。。。。。。。事业!
【在 s**********8 的大作中提到】
: 一说干, 在线人数彪升啊. 看来这是王道.
:
: so.
| s**********8
发帖数: 25265 | 17 笑喷了. 对, 该人模狗样了.
【在 S****u 的大作中提到】
: 都版主了装得庄重些有那么难嘛
| s**********8
发帖数: 25265 | 18 估计大家都是形而下学.
【在 h******e 的大作中提到】
: 宾语。。。。。。。事业!
| s**********8
发帖数: 25265 | 19 忘考虑虫虫活力了, my bad.
so.
【在 s**********8 的大作中提到】
: higher than that bah. 要不私生子会很多.
: simple math. 干二十次, 每次99%, 那么20%会种上. but not that high number. so.
: ...
| s**********8
发帖数: 25265 | 20 大哥放心,额们会努力的.
--虫虫
【在 s**********8 的大作中提到】
: 忘考虑虫虫活力了, my bad.
:
: so.
| | | s**********8
发帖数: 25265 | 21 加油
--太尉
【在 s**********8 的大作中提到】
: 大哥放心,额们会努力的.
: --虫虫
| l*****f
发帖数: 359 | 22 HUDs cannot be sold for profit? Isn't this very strange?
in
【在 s**********8 的大作中提到】
: DEFINITIONS:
: I. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit
: patients
: by treating or diagnosing a disease or condition that affects fewer than 4,
: 000
: individuals in the United States per year.
: II. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
: (FDA) approval of an HDE permits the marketing of an HUD, subject to
: restrictions
: on charges and use. Specifically, HUDs cannot be sold for profit, except in
| s**********8
发帖数: 25265 | 23 why not?
【在 l*****f 的大作中提到】
: HUDs cannot be sold for profit? Isn't this very strange?
:
: in
| l*****f
发帖数: 359 | 24 in your post, it says:
Specifically, HUDs cannot be sold for profit, except in
the limited circumstance when indicated for use in children, and can only be
administered in facilities after IRB approval is obtained, except in certain
emergencies.
【在 s**********8 的大作中提到】
: why not?
| s**********8
发帖数: 25265 | 25 i dont know. no experience for this, yet.
be
certain
【在 l*****f 的大作中提到】
: in your post, it says:
: Specifically, HUDs cannot be sold for profit, except in
: the limited circumstance when indicated for use in children, and can only be
: administered in facilities after IRB approval is obtained, except in certain
: emergencies.
| l*****f
发帖数: 359 | 26 ah, i c
i heard of something called the Medical Device Innovation Initiative by FDA.
have you guys ever taken advantage of that?
【在 s**********8 的大作中提到】
: i dont know. no experience for this, yet.
:
: be
: certain
| s**********8
发帖数: 25265 | 27 加点毛的马上上首页, 钻风这口味.
【在 s**********8 的大作中提到】
: 加油
: --太尉
|
|
