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Google Keyword Rankings for : software fda regulation
1
https://www.fda.gov/media/80958/download
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https://www.fda.gov/media/80958/download
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2
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
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3
https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
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https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
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4
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
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5
https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
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https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
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6
https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
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https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
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7
https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-which-fda-will-exercise-enforcement-discretion
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https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-which-fda-will-exercise-enforcement-discretion
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8
https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device
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https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device
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9
https://www2.deloitte.com/us/en/pages/public-sector/articles/software-as-a-medical-device-fda.html
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https://www2.deloitte.com/us/en/pages/public-sector/articles/software-as-a-medical-device-fda.html
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10
https://www.raps.org/news-and-articles/news-articles/2022/9/legal-expert-fdas-cds-software-guidance-is-a-disas
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https://www.raps.org/news-and-articles/news-articles/2022/9/legal-expert-fdas-cds-software-guidance-is-a-disas
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11
https://www.ropesgray.com/en/newsroom/alerts/2022/october/is-your-clinical-decision-support-software-a-medical-device
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https://www.ropesgray.com/en/newsroom/alerts/2022/october/is-your-clinical-decision-support-software-a-medical-device
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12
https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/08/how-fda-regulates-artificial-intelligence-in-medical-products
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https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/08/how-fda-regulates-artificial-intelligence-in-medical-products
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13
https://www.healthcareitnews.com/news/fda-hopes-draft-guidance-device-software-will-offer-clarity-simplicity
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https://www.healthcareitnews.com/news/fda-hopes-draft-guidance-device-software-will-offer-clarity-simplicity
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14
https://www.dlapiper.com/en/us/insights/publications/2022/09/your-clinical-decision-support-software-may-now-be-regulated-by-fda-as-a-medical-device/
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https://www.dlapiper.com/en/us/insights/publications/2022/09/your-clinical-decision-support-software-may-now-be-regulated-by-fda-as-a-medical-device/
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15
https://digitalhealth.folio3.com/blog/fda-software-as-a-medical-device/
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https://digitalhealth.folio3.com/blog/fda-software-as-a-medical-device/
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16
https://www.fiercehealthcare.com/regulatory/fda-medical-device-innovation-software-upgrades-scott-gottlieb-bradley-merrill-thompson
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https://www.fiercehealthcare.com/regulatory/fda-medical-device-innovation-software-upgrades-scott-gottlieb-bradley-merrill-thompson
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17
https://www.emergobyul.com/blog/2021/04/us-fda-removes-some-software-functions-medical-device-classification-regulations
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https://www.emergobyul.com/blog/2021/04/us-fda-removes-some-software-functions-medical-device-classification-regulations
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18
https://www.fiercebiotech.com/medtech/fda-delivers-regulatory-guidance-ai-software-and-clinical-decisionmaking-aids
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https://www.fiercebiotech.com/medtech/fda-delivers-regulatory-guidance-ai-software-and-clinical-decisionmaking-aids
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19
https://pubmed.ncbi.nlm.nih.gov/1482971/
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https://pubmed.ncbi.nlm.nih.gov/1482971/
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20
https://www.medtechdive.com/news/fda-final-guidance-clinical-decision-support/632824/
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https://www.medtechdive.com/news/fda-final-guidance-clinical-decision-support/632824/
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21
https://www.regulations.gov/docket/FDA-2019-N-1185
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https://www.regulations.gov/docket/FDA-2019-N-1185
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22
https://www.jdsupra.com/legalnews/fda-to-regulate-more-ai-software-tools-1204223/
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https://www.jdsupra.com/legalnews/fda-to-regulate-more-ai-software-tools-1204223/
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23
https://www.youtube.com/watch?v=gbpMTeWuryk
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https://www.youtube.com/watch?v=gbpMTeWuryk
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24
https://www.akingump.com/en/news-insights/fda-changes-direction-in-final-cds-guidance.html
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https://www.akingump.com/en/news-insights/fda-changes-direction-in-final-cds-guidance.html
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25
https://www.accruent.com/resources/blog-posts/fda-regulatory-compliance-software-everything-you-need-know-0
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https://www.accruent.com/resources/blog-posts/fda-regulatory-compliance-software-everything-you-need-know-0
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26
https://www.cov.com/en/news-and-insights/insights/2022/10/5-key-takeaways-from-fdas-final-guidance-on-regulation-of-clinical-decision-support-software-fda-outlines-significant-changes-for-cds
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https://www.cov.com/en/news-and-insights/insights/2022/10/5-key-takeaways-from-fdas-final-guidance-on-regulation-of-clinical-decision-support-software-fda-outlines-significant-changes-for-cds
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27
https://www.wsgr.com/en/insights/fda-finalizes-clinical-decision-support-cds-software-guidance.html
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https://www.wsgr.com/en/insights/fda-finalizes-clinical-decision-support-cds-software-guidance.html
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28
https://medtech.pharmaintelligence.informa.com/MT145935/Regulating-Software-As-A-Medical-Device-Will-Take-Paradigm-Shift-Former-FDA-Chief-Counsel-Says
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https://medtech.pharmaintelligence.informa.com/MT145935/Regulating-Software-As-A-Medical-Device-Will-Take-Paradigm-Shift-Former-FDA-Chief-Counsel-Says
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29
https://www.crowell.com/files/20220107-The-State-Of-FDA-Regulation-Of-Software-As-A-Medical-Device.pdf
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https://www.crowell.com/files/20220107-The-State-Of-FDA-Regulation-Of-Software-As-A-Medical-Device.pdf
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30
https://www.natlawreview.com/article/coverage-fda-s-aiml-medical-devices-workshop-part-1-history-fda-software-regulation
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https://www.natlawreview.com/article/coverage-fda-s-aiml-medical-devices-workshop-part-1-history-fda-software-regulation
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31
https://healthitanalytics.com/news/fda-releases-guidance-on-ai-driven-clinical-decision-support-tools
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https://healthitanalytics.com/news/fda-releases-guidance-on-ai-driven-clinical-decision-support-tools
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32
https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions
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https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions
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33
https://www.sidley.com/en/insights/newsupdates/2022/10/one-step-forward-two-steps-back-fdas-final-guidance-on-clinical-decision-software
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https://www.sidley.com/en/insights/newsupdates/2022/10/one-step-forward-two-steps-back-fdas-final-guidance-on-clinical-decision-software
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34
https://namsa.com/fda-releases-guidance-clinical-decision-support-software/
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https://namsa.com/fda-releases-guidance-clinical-decision-support-software/
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35
https://jamanetwork.com/journals/jama/fullarticle/2687221
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https://jamanetwork.com/journals/jama/fullarticle/2687221
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36
https://ipo.org/wp-content/uploads/2022/02/IPO-SW-Med-Device-Committee-Report-2021-final.pdf
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https://ipo.org/wp-content/uploads/2022/02/IPO-SW-Med-Device-Committee-Report-2021-final.pdf
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37
https://www.nature.com/articles/s41746-020-00324-0
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https://www.nature.com/articles/s41746-020-00324-0
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38
https://techblog.integrant.com/fda-compliant-software-best-practices
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https://techblog.integrant.com/fda-compliant-software-best-practices
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39
https://www.cdc.gov/cliac/docs/addenda/cliac0210/Addendum-V.pdf
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https://www.cdc.gov/cliac/docs/addenda/cliac0210/Addendum-V.pdf
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40
https://library.ul.com/wp-content/uploads/sites/40/2015/02/UL_WP_Final_The-US-FDAs-Regulation-and-Oversight-of-Mobile-Medical-Applications_v6_HR.pdf
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https://library.ul.com/wp-content/uploads/sites/40/2015/02/UL_WP_Final_The-US-FDAs-Regulation-and-Oversight-of-Mobile-Medical-Applications_v6_HR.pdf
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41
https://www.repository.law.indiana.edu/fclj/vol50/iss3/10/
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https://www.repository.law.indiana.edu/fclj/vol50/iss3/10/
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42
https://www.healthindustrywashingtonwatch.com/2022/09/articles/other-health-policy-developments/other-fda-developments/fda-announces-final-guidance-on-clinical-decision-support-software/
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https://www.healthindustrywashingtonwatch.com/2022/09/articles/other-health-policy-developments/other-fda-developments/fda-announces-final-guidance-on-clinical-decision-support-software/
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43
https://www.regdesk.co/fda-guidance-on-computer-software-assurance-determination/
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https://www.regdesk.co/fda-guidance-on-computer-software-assurance-determination/
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44
https://academic.oup.com/jlb/article/1/2/202/2886668
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https://academic.oup.com/jlb/article/1/2/202/2886668
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45
https://www.mddionline.com/news/draft-revision-fdas-medical-device-software-policy-raises-warning-flags
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https://www.mddionline.com/news/draft-revision-fdas-medical-device-software-policy-raises-warning-flags
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46
https://www.foley.com/en/insights/publications/2022/09/fda-clinical-decision-support-software-guidance
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https://www.foley.com/en/insights/publications/2022/09/fda-clinical-decision-support-software-guidance
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47
https://informaconnect.com/eu-fda-regulating-medtech-ai-whitepaper/
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https://informaconnect.com/eu-fda-regulating-medtech-ai-whitepaper/
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48
https://www.arnoldporter.com/en/perspectives/advisories/2022/10/fda-releases-significantly-revised-final-clinical
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https://www.arnoldporter.com/en/perspectives/advisories/2022/10/fda-releases-significantly-revised-final-clinical
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49
https://www.complianceonline.com/fda-medical-device-software-regulation-nist-guidance-reports-webinar-training-704749-prdw
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https://www.complianceonline.com/fda-medical-device-software-regulation-nist-guidance-reports-webinar-training-704749-prdw
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50
https://www.morganlewis.com/pubs/2016/11/top-takeaways-from-fda-draft-guidance-on-software-as-a-medical-device
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https://www.morganlewis.com/pubs/2016/11/top-takeaways-from-fda-draft-guidance-on-software-as-a-medical-device
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51
https://www.statnews.com/2022/09/27/health-fda-artificial-intelligence-guidance-sepsis/
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https://www.statnews.com/2022/09/27/health-fda-artificial-intelligence-guidance-sepsis/
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52
https://siliconvalleysoftwarelaw.com/can-software-be-subject-to-fda-regulation/
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https://siliconvalleysoftwarelaw.com/can-software-be-subject-to-fda-regulation/
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53
https://www.cmhealthlaw.com/2022/10/fda-issues-final-guidance-on-clinical-decision-support-software/
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https://www.cmhealthlaw.com/2022/10/fda-issues-final-guidance-on-clinical-decision-support-software/
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54
https://www.ebglaw.com/insights/fda-cds-software-regulation-the-latest-guidance-on-clinical-decision-support-software/
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https://www.ebglaw.com/insights/fda-cds-software-regulation-the-latest-guidance-on-clinical-decision-support-software/
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55
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3719407
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https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3719407
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56
https://www.modernhealthcare.com/article/20171207/NEWS/171209889/fda-attempts-to-ease-regulatory-burden-on-software-developers
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https://www.modernhealthcare.com/article/20171207/NEWS/171209889/fda-attempts-to-ease-regulatory-burden-on-software-developers
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57
https://nixongwiltlaw.com/nlg-blog/2022/10/10/fda-issues-final-guidance-on-clinical-decision-support-software-and-software-as-a-medical-device-key-takeaways-and-what-it-means-for-digital-health-companies
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https://nixongwiltlaw.com/nlg-blog/2022/10/10/fda-issues-final-guidance-on-clinical-decision-support-software-and-software-as-a-medical-device-key-takeaways-and-what-it-means-for-digital-health-companies
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58
https://www.reuters.com/legal/litigation/initial-upgrade-complete-federal-legislative-action-is-necessary-regulate-dr-2022-11-14/
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https://www.reuters.com/legal/litigation/initial-upgrade-complete-federal-legislative-action-is-necessary-regulate-dr-2022-11-14/
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59
https://www.thompsoncoburn.com/insights/blogs/life-sciences-decoded/post/2017-08-11/fda-s-health-software-precert-program-to-fast-track-innovation
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https://www.thompsoncoburn.com/insights/blogs/life-sciences-decoded/post/2017-08-11/fda-s-health-software-precert-program-to-fast-track-innovation
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60
https://www.jstor.org/stable/26659891
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https://www.jstor.org/stable/26659891
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61
https://www.mwe.com/insights/fda-issues-long-awaited-final-clinical-decision-support-software-guidance/
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https://www.mwe.com/insights/fda-issues-long-awaited-final-clinical-decision-support-software-guidance/
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62
https://sterlingmedicaldevices.com/thought-leadership/medical-device-design-industry-blog/fda-medical-device-regulation-guidance-for-2022/
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https://sterlingmedicaldevices.com/thought-leadership/medical-device-design-industry-blog/fda-medical-device-regulation-guidance-for-2022/
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63
https://www.thefdalawblog.com/2021/04/fda-updates-the-regulatory-definitions-of-certain-software-types-for-consistency-with-21st-century-cures-act-exclusions/
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https://www.thefdalawblog.com/2021/04/fda-updates-the-regulatory-definitions-of-certain-software-types-for-consistency-with-21st-century-cures-act-exclusions/
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64
https://www.covingtondigitalhealth.com/2019/10/fda-issues-updated-guidance-on-the-regulation-of-digital-health-technologies/
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https://www.covingtondigitalhealth.com/2019/10/fda-issues-updated-guidance-on-the-regulation-of-digital-health-technologies/
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65
https://www.mondaq.com/unitedstates/healthcare/1071538/fda-conforms-regulations-to-exclude-certain-software-functions-from-the-definition-of-device
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https://www.mondaq.com/unitedstates/healthcare/1071538/fda-conforms-regulations-to-exclude-certain-software-functions-from-the-definition-of-device
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66
https://idea2impact.org/resources/fda-resources/
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https://idea2impact.org/resources/fda-resources/
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67
https://www.mintz.com/insights-center/viewpoints/2017-10-03-building-health-app-part-3-what-you-need-know-about-fdas
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https://www.mintz.com/insights-center/viewpoints/2017-10-03-building-health-app-part-3-what-you-need-know-about-fdas
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68
https://www.mobihealthnews.com/news/north-america/fda-releases-revised-draft-guidance-cds-software-final-guidelines-device
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https://www.mobihealthnews.com/news/north-america/fda-releases-revised-draft-guidance-cds-software-final-guidelines-device
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69
https://www.quantib.com/blog/a-101-guide-to-the-fda-regulatory-process-for-ai-radiology-software
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https://www.quantib.com/blog/a-101-guide-to-the-fda-regulatory-process-for-ai-radiology-software
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70
https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12278
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https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12278
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71
https://www.mastercontrol.com/compliance/fda/compliance-software/
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https://www.mastercontrol.com/compliance/fda/compliance-software/
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72
https://www.ijhpm.com/article_4152_fa6b93857538d51aca3f6bdb06191e9f.pdf
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https://www.ijhpm.com/article_4152_fa6b93857538d51aca3f6bdb06191e9f.pdf
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73
https://www.coursera.org/lecture/introduction-to-medical-software/the-regulatory-process-BOtsE
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https://www.coursera.org/lecture/introduction-to-medical-software/the-regulatory-process-BOtsE
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74
https://www.fdanews.com/ext/resources/files/2019/09-26-19-Guidances.pdf?1569528271
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https://www.fdanews.com/ext/resources/files/2019/09-26-19-Guidances.pdf?1569528271
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75
https://www.stinson.com/newsroom-publications-FDA_Issues_a_Second_Draft_Guidance_on_Clinical_Decision_Support_Software
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https://www.stinson.com/newsroom-publications-FDA_Issues_a_Second_Draft_Guidance_on_Clinical_Decision_Support_Software
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76
https://www.stata.com/stata-fda-compliance/
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https://www.stata.com/stata-fda-compliance/
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77
https://www.meddeviceonline.com/doc/fda-finalizes-regulation-for-certain-0001
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https://www.meddeviceonline.com/doc/fda-finalizes-regulation-for-certain-0001
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78
https://simbex.com/regulatory-apr21/
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https://simbex.com/regulatory-apr21/
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79
https://ieeexplore.ieee.org/document/262999
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https://ieeexplore.ieee.org/document/262999
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80
https://www.prweb.com/releases/fdanews_announces_digital_health_regulation_navigating_fdas_rules_for_software_as_a_medical_device_management_report/prweb18231205.htm
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81
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82
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83
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86
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87
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88
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89
https://www.americanconference.com/fda-boot-camp-medical-devices-edition-670l16-chi/wp-content/uploads/sites/1052/2017/04/670L16-CHI_Day-1_2-30pm_P1_-__Seth_A__Mailhot.pdf
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90
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92
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93
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96
https://www.johner-institute.com/articles/software-iec-62304/software-as-medical-device/
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97
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