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Google Keyword Rankings for : fda hde guidance
1
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program
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2
https://www.fda.gov/media/74307/download
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https://www.fda.gov/media/74307/download
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3
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption
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https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption
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4
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-use-device-hud-designations
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-use-device-hud-designations
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5
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm
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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm
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6
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during
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7
https://www.fda.gov/medical-devices/humanitarian-device-exemption/humanitarian-device-exemption-hde-postmarket-activities
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https://www.fda.gov/medical-devices/humanitarian-device-exemption/humanitarian-device-exemption-hde-postmarket-activities
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8
https://www.fda.gov/media/130442/download
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https://www.fda.gov/media/130442/download
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9
https://www.regulations.gov/docket/FDA-2014-D-0223/document
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https://www.regulations.gov/docket/FDA-2014-D-0223/document
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10
https://www.fdanews.com/ext/resources/files/03/03-17-14-HDE.pdf
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https://www.fdanews.com/ext/resources/files/03/03-17-14-HDE.pdf
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11
https://www.reginfo.gov/public/do/DownloadDocument?objectID=64421001
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https://www.reginfo.gov/public/do/DownloadDocument?objectID=64421001
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12
https://www.choa.org/-/media/Files/Childrens/research/irb/tools-and-guidance/hud-guidance.pdf?la=en&hash=29BF16283CA1BE3C614BFD05C83F4E73CA508012
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https://www.choa.org/-/media/Files/Childrens/research/irb/tools-and-guidance/hud-guidance.pdf?la=en&hash=29BF16283CA1BE3C614BFD05C83F4E73CA508012
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13
https://www.engage.hoganlovells.com/knowledgeservices/news/final-guidance-provides-additional-clarity-to-the-humanitarian-device-exemption-program
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https://www.engage.hoganlovells.com/knowledgeservices/news/final-guidance-provides-additional-clarity-to-the-humanitarian-device-exemption-program
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14
https://research.cuanschutz.edu/docs/librariesprovider148/comirb_documents/guidance/humanitarian-use-devices-guidance.doc?sfvrsn=78172fb9_2
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https://research.cuanschutz.edu/docs/librariesprovider148/comirb_documents/guidance/humanitarian-use-devices-guidance.doc?sfvrsn=78172fb9_2
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15
https://www.healthlawadvisor.com/2019/09/25/fda-guidance-clarifies-hde-program-review/
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https://www.healthlawadvisor.com/2019/09/25/fda-guidance-clarifies-hde-program-review/
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16
https://feinstein.northwell.edu/sites/northwell.edu/files/2019-07/Humanitarian-Use-Device-Guidance-JUN2019.pdf
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https://feinstein.northwell.edu/sites/northwell.edu/files/2019-07/Humanitarian-Use-Device-Guidance-JUN2019.pdf
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17
https://www.advarra.com/blog/new-hud-guidance/
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https://www.advarra.com/blog/new-hud-guidance/
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18
https://www.washington.edu/research/hsd/guidance/hud/
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https://www.washington.edu/research/hsd/guidance/hud/
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19
https://blogs.vcu.edu/research/2019/09/06/recently-posted-fda-guidance-documents-3/
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https://blogs.vcu.edu/research/2019/09/06/recently-posted-fda-guidance-documents-3/
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20
https://www.federalregister.gov/documents/2014/03/18/2014-05900/humanitarian-device-exemption-questions-and-answers-draft-guidance-for-humanitarian-device-exemption
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https://www.federalregister.gov/documents/2014/03/18/2014-05900/humanitarian-device-exemption-questions-and-answers-draft-guidance-for-humanitarian-device-exemption
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21
https://irb.utah.edu/guidelines/fda-requirements/humanitarian-devices.php
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https://irb.utah.edu/guidelines/fda-requirements/humanitarian-devices.php
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22
https://ora.research.ucla.edu/OHRPP/Documents/Policy/8/HUD_Guidance_and_Policy.pdf
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https://ora.research.ucla.edu/OHRPP/Documents/Policy/8/HUD_Guidance_and_Policy.pdf
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23
https://www.medtechdive.com/news/fda-finalizes-guidance-on-hdes-after-advamed-scrutiny/562394/
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https://www.medtechdive.com/news/fda-finalizes-guidance-on-hdes-after-advamed-scrutiny/562394/
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24
https://www.mdanderson.org/content/dam/mdanderson/documents/Research-Centers-&-Institutes/office-of-clinical-research-administration/hrpp-manual/guidance/Humanitarian_Use_Device.pdf
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https://www.mdanderson.org/content/dam/mdanderson/documents/Research-Centers-&-Institutes/office-of-clinical-research-administration/hrpp-manual/guidance/Humanitarian_Use_Device.pdf
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25
https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/fda814_1.html
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https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/fda814_1.html
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26
https://www.aurorahealthcare.org/rspp-irb/downloads/research-forms/humanitarian-use-devices
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https://www.aurorahealthcare.org/rspp-irb/downloads/research-forms/humanitarian-use-devices
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27
https://www.adventhealthresearchinstitute.com/sites/default/files/2019-03/HRP-827%20INVESTIGATOR%20GUIDANCE%20-%20Humanitarian%20Use%20Devices_1.pdf
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https://www.adventhealthresearchinstitute.com/sites/default/files/2019-03/HRP-827%20INVESTIGATOR%20GUIDANCE%20-%20Humanitarian%20Use%20Devices_1.pdf
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28
https://www.hhs.gov/guidance/document/humanitarian-device-exemption-hde-program-guidance-industry-and-food-and-drug
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https://www.hhs.gov/guidance/document/humanitarian-device-exemption-hde-program-guidance-industry-and-food-and-drug
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29
https://www.raps.org/news-and-articles/news-articles/2019/9/humanitarian-device-exemptions-fda-finalizes-guid
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https://www.raps.org/news-and-articles/news-articles/2019/9/humanitarian-device-exemptions-fda-finalizes-guid
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30
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814/subpart-H
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https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814/subpart-H
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31
https://www.regdesk.co/fda-guidance-on-supplements-for-pma-and-hde-submissions/
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https://www.regdesk.co/fda-guidance-on-supplements-for-pma-and-hde-submissions/
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32
https://www.research.uky.edu/uploads/ori-d540000-irb-summary-medical-devices-humanitarian-use-devices-pdf
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https://www.research.uky.edu/uploads/ori-d540000-irb-summary-medical-devices-humanitarian-use-devices-pdf
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33
https://www.cardiomedllc.com/wp-content/uploads/2014/06/HUDs-and-HDEs.pdf
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https://www.cardiomedllc.com/wp-content/uploads/2014/06/HUDs-and-HDEs.pdf
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34
https://www.govinfo.gov/content/pkg/FR-2022-06-07/pdf/2022-12176.pdf
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https://www.govinfo.gov/content/pkg/FR-2022-06-07/pdf/2022-12176.pdf
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35
https://ryortho.com/breaking/humanitarian-device-exemption-fda-guidance-finalized/
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https://ryortho.com/breaking/humanitarian-device-exemption-fda-guidance-finalized/
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36
https://www.natlawreview.com/article/fda-guidance-clarifies-hde-program-review
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https://www.natlawreview.com/article/fda-guidance-clarifies-hde-program-review
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37
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051374/
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051374/
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38
https://uk.practicallaw.thomsonreuters.com/w-015-3325?transitionType=Default&contextData=(sc.Default)
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https://uk.practicallaw.thomsonreuters.com/w-015-3325?transitionType=Default&contextData=(sc.Default)
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39
https://www.360dx.com/regulatory-news-fda-approvals/fda-issues-final-guidance-humanitarian-device-exemption-program
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https://www.360dx.com/regulatory-news-fda-approvals/fda-issues-final-guidance-humanitarian-device-exemption-program
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40
https://www.womans.org/-/media/files/womans/research/policies/humanitarian-use-devices.pdf?la=en&hash=BC54AC7B54772508FB754A341B14AD82FB68513D
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https://www.womans.org/-/media/files/womans/research/policies/humanitarian-use-devices.pdf?la=en&hash=BC54AC7B54772508FB754A341B14AD82FB68513D
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41
https://www.massdevice.com/fda-releases-humanitarian-device-exemption-final-guidance/
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https://www.massdevice.com/fda-releases-humanitarian-device-exemption-final-guidance/
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42
https://your.yale.edu/sites/default/files/irbpolicy610hudfinal.pdf
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https://your.yale.edu/sites/default/files/irbpolicy610hudfinal.pdf
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43
https://www.bibamedtech.com/biba-briefings-top-stories/the-fda-finalises-its-draft-guidance-on-the-humanitarian-device-exemption-programme/
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https://www.bibamedtech.com/biba-briefings-top-stories/the-fda-finalises-its-draft-guidance-on-the-humanitarian-device-exemption-programme/
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44
https://s3.amazonaws.com/documents.jdsupra.com/ba6b6d76-aea4-406e-931a-e9f898054cc2.pdf
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https://s3.amazonaws.com/documents.jdsupra.com/ba6b6d76-aea4-406e-931a-e9f898054cc2.pdf
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45
https://irb.upenn.edu/announcements/humanitarian-device-exemption-guidance
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https://irb.upenn.edu/announcements/humanitarian-device-exemption-guidance
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46
https://incompliancemag.com/u-s-fda-releases-draft-guidance-on-humanitarian-device-exemptions/
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https://incompliancemag.com/u-s-fda-releases-draft-guidance-on-humanitarian-device-exemptions/
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47
https://www.saintlukeskc.org/sites/default/files/2018-05/Humanitarian%20Use%20Device%20Guidance.docx
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https://www.saintlukeskc.org/sites/default/files/2018-05/Humanitarian%20Use%20Device%20Guidance.docx
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48
https://sbir.cancer.gov/commercialization/fda/radiological-devices
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https://sbir.cancer.gov/commercialization/fda/radiological-devices
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49
https://www.unr.edu/research-integrity/human-research/human-research-protection-policy-manual/125-humanitarian-use-devices
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https://www.unr.edu/research-integrity/human-research/human-research-protection-policy-manual/125-humanitarian-use-devices
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50
https://ascensionwisconsinresearchinstitute.org/-/media/Project/SXA---WI/AWRI/Files/RIP/IRB-SOPs/IRB-Guidance-HUDs_4-20-18.pdf?la=en&hash=70366F0331C62CD1BC1782E33F385E09CC0E9726
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https://ascensionwisconsinresearchinstitute.org/-/media/Project/SXA---WI/AWRI/Files/RIP/IRB-SOPs/IRB-Guidance-HUDs_4-20-18.pdf?la=en&hash=70366F0331C62CD1BC1782E33F385E09CC0E9726
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51
https://az.research.umich.edu/medschool/guidance/humanitarian-use-device-requirements-u-m-physicians-investigators
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https://az.research.umich.edu/medschool/guidance/humanitarian-use-device-requirements-u-m-physicians-investigators
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52
https://www.goodwinlaw.com/publications/2022/01/01_14-planning-for-the-end-fda-issues-draft
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https://www.goodwinlaw.com/publications/2022/01/01_14-planning-for-the-end-fda-issues-draft
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53
https://research.uci.edu/human-research-protections/clinical-research/humanitarian-use-devices/
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https://research.uci.edu/human-research-protections/clinical-research/humanitarian-use-devices/
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54
https://www.supremecourt.gov/opinions/URLs_Cited/OT2007/06-179/06-179_2.pdf
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https://www.supremecourt.gov/opinions/URLs_Cited/OT2007/06-179/06-179_2.pdf
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55
https://www.exponent.com/knowledge/alerts/2020/10/newly-issued-fda-guidance-on-use-of-iso-10993-1/
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https://www.exponent.com/knowledge/alerts/2020/10/newly-issued-fda-guidance-on-use-of-iso-10993-1/
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56
https://advance.lexis.com/open/document/openwebdocview/Humanitarian-Device-Exemption-Program-Guidance-for-Industry-and-Food-and-Drug-Administration-Staff-Availability/?pdmfid=1000522&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A5X09-9VC1-JNCK-209B-00000-00&pdcomponentid=504802
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https://advance.lexis.com/open/document/openwebdocview/Humanitarian-Device-Exemption-Program-Guidance-for-Industry-and-Food-and-Drug-Administration-Staff-Availability/?pdmfid=1000522&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A5X09-9VC1-JNCK-209B-00000-00&pdcomponentid=504802
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57
https://fda.report/media/85356/Humanitarian-Use-Device-%28HUD%29-Designations---Guidance-for-Industry-and-FDA-Staff.pdf
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https://fda.report/media/85356/Humanitarian-Use-Device-%28HUD%29-Designations---Guidance-for-Industry-and-FDA-Staff.pdf
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58
https://rgw.arizona.edu/sites/default/files/humanitarian_use_devices.pdf
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https://rgw.arizona.edu/sites/default/files/humanitarian_use_devices.pdf
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59
https://www.emergobyul.com/blog/2020/05/us-fda-temporarily-accept-changes-devices-approved-through-pma-or-hde
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https://www.emergobyul.com/blog/2020/05/us-fda-temporarily-accept-changes-devices-approved-through-pma-or-hde
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60
https://www.hpnonline.com/regulatory/article/21095982/fda-provides-transparency-and-clarity-on-the-humanitarian-device-exemption-pathway
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https://www.hpnonline.com/regulatory/article/21095982/fda-provides-transparency-and-clarity-on-the-humanitarian-device-exemption-pathway
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61
https://assets.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Research_Compliance/2020/R25.pdf
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https://assets.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Research_Compliance/2020/R25.pdf
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62
https://officeofresearch.ucsc.edu/compliance/files-irb/device-determination-worksheet.pdf
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https://officeofresearch.ucsc.edu/compliance/files-irb/device-determination-worksheet.pdf
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63
https://news.bloomberglaw.com/pharma-and-life-sciences/fda-issues-draft-guidance-answering-questions-about-humanitarian-use-devices
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https://news.bloomberglaw.com/pharma-and-life-sciences/fda-issues-draft-guidance-answering-questions-about-humanitarian-use-devices
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64
https://medtech.pharmaintelligence.informa.com/MT125613/New-FDA-Guidance-Expands-HUD-Patient-Limit
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https://medtech.pharmaintelligence.informa.com/MT125613/New-FDA-Guidance-Expands-HUD-Patient-Limit
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65
https://www.irb.emory.edu/_includes/documents/sections/hud-treatment-protocol-outline.docx
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https://www.irb.emory.edu/_includes/documents/sections/hud-treatment-protocol-outline.docx
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66
https://www.mondaq.com/unitedstates/x/302928/food+drugs+law/FDA+Issues+Draft+Guidance+On+Humanitarian+Device+Exemption
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https://www.mondaq.com/unitedstates/x/302928/food+drugs+law/FDA+Issues+Draft+Guidance+On+Humanitarian+Device+Exemption
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67
https://foleyhoag.com/news-and-insights/publications/alerts-and-updates/2022/april/fda-issues-draft-guidance-recommending-race-and-ethnicity-diversity-plans-for-clinical-trial-sponsor/
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https://foleyhoag.com/news-and-insights/publications/alerts-and-updates/2022/april/fda-issues-draft-guidance-recommending-race-and-ethnicity-diversity-plans-for-clinical-trial-sponsor/
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68
https://www.meddeviceonline.com/doc/does-the-humanitarian-device-exemption-process-work-and-is-it-worth-pursuing-0001
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https://www.meddeviceonline.com/doc/does-the-humanitarian-device-exemption-process-work-and-is-it-worth-pursuing-0001
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69
https://rarediseases.org/wp-content/uploads/2018/08/NORD-2018-Comments-on-FDA-HDE-Program.pdf
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https://rarediseases.org/wp-content/uploads/2018/08/NORD-2018-Comments-on-FDA-HDE-Program.pdf
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70
https://tracs.unc.edu/docs/regulatory/IDE_FDA_Guidance_and_FAQs.pdf
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https://tracs.unc.edu/docs/regulatory/IDE_FDA_Guidance_and_FAQs.pdf
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71
https://www.fdli.org/2022/04/premarket-approval-application-pma-humanitarian-device-exemption-hde/
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https://www.fdli.org/2022/04/premarket-approval-application-pma-humanitarian-device-exemption-hde/
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72
https://www.research.chop.edu/sites/default/files/2021-08/ide_humanitarian_use_device_checklist_fillable.pdf
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https://www.research.chop.edu/sites/default/files/2021-08/ide_humanitarian_use_device_checklist_fillable.pdf
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73
https://www.wiley.law/alert-FDA-Provides-New-Draft-Guidance-on-Premarket-Submissions-for-Device-Software-Functions
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https://www.wiley.law/alert-FDA-Provides-New-Draft-Guidance-on-Premarket-Submissions-for-Device-Software-Functions
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74
https://starfishmedical.com/blog/fda-approved-or-cleared-medical-device/
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https://starfishmedical.com/blog/fda-approved-or-cleared-medical-device/
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75
https://www.intertek.com/blog/2022-07-19-cybersecurity/
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https://www.intertek.com/blog/2022-07-19-cybersecurity/
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76
https://www.wellmark.com/-/media/sites/public/files/medical-policies/humanitarian-use-devices
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https://www.wellmark.com/-/media/sites/public/files/medical-policies/humanitarian-use-devices
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77
https://scholar.harvard.edu/files/sinha/files/jama_darrow_2021_sc_210002.pdf
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https://scholar.harvard.edu/files/sinha/files/jama_darrow_2021_sc_210002.pdf
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78
https://www.sciencedirect.com/science/article/pii/S2452302X16300183
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79
https://www.gao.gov/assets/gao-15-815.pdf
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80
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81
https://irb.northwestern.edu/docs/guidance-on-the-use-of-investigational-medical-devices-in-human-subjects-research.pdf
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82
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83
https://irb.ucsf.edu/investigational-devices
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84
https://jpro.springeropen.com/articles/10.1186/s41687-022-00444-z
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85
https://research.iu.edu/policies/human-subjects-irb/humanitarian-use-devices.html
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86
http://fmdic.org/wp-content/uploads/2020/01/508_1677.pdf
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87
https://emmainternational.com/changing-pma-or-hde-devices-during-covid-19/
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88
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89
https://www.healthaffairs.org/doi/10.1377/hlthaff.2010.0157
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90
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91
https://quizlet.com/393216637/humanitarian-use-devices-huds-flash-cards/
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92
https://medicaldealer.com/fda-provides-transparency-clarity-humanitarian-device-exemption-pathway-helping-bring-life-saving-medical-devices-patients-need/
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93
https://www.kkblaw.com/no-time-like-present-fda-issues-numerous-device-specific-guidance-documents-2018-1st-installment/
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94
https://medicare.fcso.com/clinical_trials/137306.asp
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95
https://www.linkedin.com/pulse/episode-16-supplements-approved-pma-hde-submissions-during-pudwill
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96
https://www.upstateresearch.org/assets/fda_ivd_guidance.pdf
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