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Volumn 2, Issue 3, 2016, Pages 669-696

A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States

Author keywords

Food and drug law; Human enhancement; Medical devices; Neuroscience; Regulation; Transcranial direct current stimulation (tDCS)

Indexed keywords


EID: 85018279328     PISSN: None     EISSN: 20539711     Source Type: Journal    
DOI: 10.1093/jlb/lsv039     Document Type: Article
Times cited : (65)

References (94)
  • 1
    • 85054990622 scopus 로고    scopus 로고
    • http://www.ncbi.nlm.nih.gov/ pubmed/?term=(%22transcranial+direct+current+stimulation%22%5BTitle%5D)+OR+tdcs%5BTitle %5D
  • 2
    • 84889650900 scopus 로고    scopus 로고
    • Therapeutic Effects of Non-Invasive Brain Stimulation with Direct Currents (tDCS) in Neuropsychiatric Diseases
    • Min-Fang Kuo, Walter Paulus & Michael A. Nitsche, Therapeutic Effects of Non-Invasive Brain Stimulation with Direct Currents (tDCS) in Neuropsychiatric Diseases, 85NEUROIMAGE 948 (2014)
    • (2014) NEUROIMAGE , vol.85 , pp. 948
    • Kuo, M.-F.1    Paulus, W.2    Nitsche, M.A.3
  • 3
    • 84889678424 scopus 로고    scopus 로고
    • Battery PoweredThought: Enhancement of Attention, Learning, and Memory in Healthy AdultsUsing Transcranial Direct Current Stimulation
    • Brian A.Coffman, Vincent P.Clark & Raja Parasuraman, Battery PoweredThought: Enhancement of Attention, Learning, and Memory in Healthy AdultsUsing Transcranial Direct Current Stimulation, 85 NEUROIMAGE 895 (2014)
    • (2014) NEUROIMAGE , vol.85 , pp. 895
    • Coffman, B.A.1    Vincent, P.C.2    Parasuraman, R.3
  • 4
    • 85054984639 scopus 로고    scopus 로고
    • Early Adopters of the Magical Thinking Cap: A Study On Do-It-Yourself (DIY) Transcranial Direct Current Stimulation (tDCS) User Community
    • Anita Jwa, Early Adopters of the Magical Thinking Cap: A Study On Do-It-Yourself (DIY) Transcranial Direct Current Stimulation (tDCS) User Community, 2 J. L. BIOSCI., 292, 307 (2015)
    • (2015) J. L. BIOSCI , vol.2 , pp. 292-307
    • Jwa, A.1
  • 5
    • 85054974995 scopus 로고    scopus 로고
    • accessed Aug. 25, 2015
    • http://neuromodec.com/events/nyc-neuromodulation-conference-2015/ (accessed Aug. 25, 2015)
  • 6
    • 84884152652 scopus 로고    scopus 로고
    • Neuroscience: Transcranial Devices Are Not Playthings
    • Marom Bikson, Sven Bestmann & Dylan Edwards, Neuroscience: Transcranial Devices Are Not Playthings, 501 NATURE 167 (2013)
    • (2013) NATURE , vol.501 , pp. 167
    • Bikson, M.1    Bestmann, S.2    Edwards, D.3
  • 7
    • 84928232165 scopus 로고    scopus 로고
    • Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): Review and Recommendations from an Expert Panel
    • published online first Dec. 2 2014
    • Felipe Fregni et al., Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): Review and Recommendations from an Expert Panel, 32 CLIN. RES. REGUL. AFF., 22, published online first Dec. 2 2014
    • CLIN. RES. REGUL. AFF , vol.32 , pp. 22
    • Fregni, F.1
  • 8
    • 84916618714 scopus 로고    scopus 로고
    • Cognitive Enhancement or Cognitive Cost: Trait-Specific Outcomes of Brain Stimulation in the Case of Mathematics Anxiety
    • Amar Sarkar, Ann Dowker & Roi Cohen Kadosh, Cognitive Enhancement or Cognitive Cost: Trait-Specific Outcomes of Brain Stimulation in the Case of Mathematics Anxiety, 34 J. NEUROSCI. 16605 (2014)
    • (2014) J. NEUROSCI , vol.34 , pp. 16605
    • Sarkar, A.1    Dowker, A.2    Kadosh, R.C.3
  • 9
  • 10
    • 84938285144 scopus 로고    scopus 로고
    • Neurostimulation Devices for Cognitive Enhancement: Toward a Comprehensive Regulatory Framework
    • Veljko Dubljevic, Neurostimulation Devices for Cognitive Enhancement: Toward a Comprehensive Regulatory Framework, 8 NEUROETHICS 115 (2015)
    • (2015) NEUROETHICS , vol.8 , pp. 115
    • Dubljevic, V.1
  • 11
    • 84929501956 scopus 로고    scopus 로고
    • Do-it-Yourself Brain Stimulation: A Regulatory Model
    • Hannah Maslen et al., Do-it-Yourself Brain Stimulation: A Regulatory Model, 41 J. MED. ETHICS 413 (2015)
    • (2015) J. MED. ETHICS , vol.41 , pp. 413
    • Maslen, H.1
  • 12
    • 84901037823 scopus 로고    scopus 로고
    • The Regulation of Cognitive Enhancement Devices: Extending the Medical Model
    • Hannah Maslen et al., The Regulation of Cognitive Enhancement Devices: Extending the Medical Model, 1 J. L. BIOSCI. 68 (2014)
    • (2014) J. L. BIOSCI , vol.1 , pp. 68
    • Maslen, H.1
  • 13
    • 84959935100 scopus 로고    scopus 로고
    • The Brain, Cognitive Enhancement Devices, and European Regulation
    • Andreas Kuersten & Roy H. Hamilton, The Brain, Cognitive Enhancement Devices, and European Regulation, 1 J. L. BIOSCI. 340 (2014)
    • (2014) J. L. BIOSCI , vol.1 , pp. 340
    • Kuersten, A.1    Hamilton, R.H.2
  • 14
    • 78751628023 scopus 로고    scopus 로고
    • Rethinking the Thinking Cap: Ethics of Neural Enhancement Using Noninvasive Brain Stimulation
    • Roy Hamilton, Samuel Messing & Anjan Chatterjee, Rethinking the Thinking Cap: Ethics of Neural Enhancement Using Noninvasive Brain Stimulation, 76NEUROLOGY 187 (2011)
    • (2011) NEUROLOGY , vol.76 , pp. 187
    • Hamilton, R.1    Messing, S.2    Chatterjee, A.3
  • 15
    • 84857270997 scopus 로고    scopus 로고
    • The Neuroethics of Non-Invasive Brain Stimulation
    • Roi Cohen Kadosh et al., The Neuroethics of Non-Invasive Brain Stimulation, 22CURR. BIOL. R108 (2012)
    • (2012) CURR. BIOL , vol.22 , pp. R108
    • Kadosh, R.C.1
  • 16
    • 84929510738 scopus 로고    scopus 로고
    • The Challenge of Crafting Policy for Do-It-Yourself Brain Stimulation
    • Nicholas S. Fitz & Peter B. Reiner, The Challenge of Crafting Policy for Do-It-Yourself Brain Stimulation, 41 J.MED. ETHICS 410 (2015)
    • (2015) J.MED. ETHICS , vol.41 , pp. 410
    • Fitz, N.S.1    Reiner, P.B.2
  • 17
    • 84940863157 scopus 로고    scopus 로고
    • The Practices of the Do-It-Yourself Brain Stimulation Community: Implications for Regulatory Proposals and Ethical Discussions
    • Anna Wexler, The Practices of the Do-It-Yourself Brain Stimulation Community: Implications for Regulatory Proposals and Ethical Discussions, J.MED. ETHICS, DOI:10.1136/medethics-2015-102704
    • J.MED. ETHICS
    • Wexler, A.1
  • 18
    • 84901065743 scopus 로고    scopus 로고
    • The Rising Tide of tDCS in the Media and Academic Literature
    • Veljko Dubljevic, Victoria Saigle & Eric Racine, The Rising Tide of tDCS in the Media and Academic Literature, 82 NEURON 731, 736 (2014)
    • (2014) NEURON , vol.82 , pp. 731-736
    • Dubljevic, V.1    Saigle, V.2    Racine, E.3
  • 19
    • 85054957141 scopus 로고    scopus 로고
    • LONGECITY (accessed Sep. 22, 2015)
    • Attaching a battery to your head, LONGECITY, 2007, http://www.longecity.org/forum/topic/19346-attachinga-battery-to-your-head/ (accessed Sep. 22, 2015)
    • (2007) Attaching a battery to your head
  • 20
    • 85054972930 scopus 로고    scopus 로고
    • BOSTONPHOENIX, Feb. 7 (accessed Sep. 22, 2015)
    • PaganKennedy, Brain-O-Matic, BOSTONPHOENIX, Feb. 7, 2007, http://thephoenix.com/boston/life/33313-brain-o-matic/ (accessed Sep. 22, 2015)
    • (2007) Brain-O-Matic
    • Kennedy, P.1
  • 22
    • 85054986351 scopus 로고    scopus 로고
    • Reddit /r/tDCS
    • Reddit /r/tDCS (http://www.reddit.com/r/tDCS/)
  • 23
    • 85054961906 scopus 로고    scopus 로고
    • http://diybio.org/
  • 24
    • 84991768872 scopus 로고    scopus 로고
    • The Quantified Self: Fundamental Disruption in Big Data Science and Biological Discovery
    • Melanie Swan, The Quantified Self: Fundamental Disruption in Big Data Science and Biological Discovery 1 BIG DATA 85, 87 (2013)
    • (2013) BIG DATA , vol.1 , pp. 85-87
    • Swan, M.1
  • 25
    • 85054974401 scopus 로고    scopus 로고
    • Suppression of Human Psychophysiological and Biochemical Stress Responses Using High-Frequency Pulse-Modulated Transdermal Electrical Neurosignaling
    • first published online Feb. 8
    • William J. Tyler et al., Suppression of Human Psychophysiological and Biochemical Stress Responses Using High-Frequency Pulse-Modulated Transdermal Electrical Neurosignaling, BIOXRIV preprint, first published online Feb. 8, 2015, doi.org/10.1101/015032
    • (2015) BIOXRIV preprint
    • Tyler, W.J.1
  • 26
    • 85054960061 scopus 로고    scopus 로고
    • The Practice of Electroconvulsive Therapy: Recommendations for Treatment
    • 2d ed
    • American Psychiatric Association, The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging, 147 (2d ed. 2000)
    • (2000) Training and Privileging , pp. 147
  • 27
    • 85054959566 scopus 로고    scopus 로고
    • (accessed Mar. 2012)
    • GoFlow, http://www.flowstateengaged.com (accessed Mar. 2012). http://web.archive.org/web/ 20120314201106/http://flowstateengaged.com/
    • GoFlow
  • 28
    • 85054957322 scopus 로고    scopus 로고
    • BLOOMBERG BUSINESSWEEK, Mar. 21(accessed Sep. 22, 2015)
    • Ashlee Vance, Buy a DIY Brain Supercharger for $100, BLOOMBERG BUSINESSWEEK, Mar. 21, 2012, http://www.businessweek.com/articles/2012-03-21/buy-a-diy-brain-super-charger-for-100 (accessed Sep. 22, 2015)
    • (2012) Buy a DIY Brain Supercharger for $100
    • Vance, A.1
  • 29
    • 85054956838 scopus 로고    scopus 로고
    • DIY Kit Overclocks Your Brain With Direct Current
    • Mar. 8(accessed Sep. 22, 2015)
    • Christopher Mims, DIY Kit Overclocks Your Brain With Direct Current, MIT TECHNOLOGY REVIEW,Mar. 8, 2012, http://www.technologyreview.com/view/427177/diy-kit-overclocks-your-brain-with-direct-current/ (accessed Sep. 22, 2015)
    • (2012) MIT TECHNOLOGY REVIEW
    • Mims, C.1
  • 30
    • 85054987996 scopus 로고    scopus 로고
    • DIYTDCS (accessed Dec. 14, 2013)
    • Go Flow Kickstarter Campaign Denied, DIYTDCS, http://www.diytdcs.com/2012/05/goflow-kickstartercampaign-denied/ (accessed Dec. 14, 2013)
    • Go Flow Kickstarter Campaign Denied
  • 31
    • 85054967580 scopus 로고    scopus 로고
    • Longecity Forum, http://www.longecity.org/forum/topic/57869-increased-cognition-with-9v-battery/
    • Longecity Forum
  • 32
    • 85054968995 scopus 로고    scopus 로고
    • (accessed Dec. 14, 2013)
    • DIYTDCS, http://www.diytdcs.com/2013/06/news-from-goflowgood-and-bad/ (accessed Dec. 14, 2013)
    • DIYTDCS
  • 33
    • 85054968051 scopus 로고    scopus 로고
    • (accessed July 1, 2014)
    • Trans Cranial Technologies, http://www.trans-cranial.com/ (accessed July 1, 2014)
    • Trans Cranial Technologies
  • 34
    • 85054964016 scopus 로고    scopus 로고
    • www.biocurrentkit.com
  • 35
    • 85054954551 scopus 로고    scopus 로고
    • www.tdcs-kit.com
  • 36
    • 85054958188 scopus 로고    scopus 로고
    • accessed between Dec. 2012 and Apr
    • www.tDCSdevicekit.com, accessed between Dec. 2012 and Apr. 2013
    • (2013)
  • 37
    • 85054979473 scopus 로고    scopus 로고
    • http://web.archive.org
  • 38
    • 85054979718 scopus 로고    scopus 로고
    • accessed Sep. 22, 2015
    • http://www.amazon.com/DSS-Chattanooga-Ionto/dp/B00FC2SRMY and http://www. isokineticsinc.com (accessed Sep. 22, 2015)
  • 40
    • 85054990364 scopus 로고    scopus 로고
    • http://web.archive.org/web/20130708144009/http://www.foc.us./
  • 41
    • 85049933102 scopus 로고    scopus 로고
    • THE NEW YORK TIMES, Oct. 28 (accessed Sep. 22, 2015)
    • Kate Murphy, Jump-Starter Kits for the Mind, THE NEW YORK TIMES, Oct. 28, 2013, http://www.nytimes.com/2013/10/29/science/jump-starter-kits-for-the-mind.html (accessed Sep. 22, 2015)
    • (2013) Jump-Starter Kits for the Mind
    • Murphy, K.1
  • 42
    • 85049958910 scopus 로고    scopus 로고
    • CNET, Aug. 9(accessed Sep. 22, 2015)
    • Nick Statt, When Wearable Tech Makes You Smarter-by Zapping Your Brain, CNET, Aug. 9, 2013, http://news.cnet.com/8301-11386 3-57597116-76/when-wearable-tech-makes-you-smarter-by-zappingyour-brain/ (accessed Sep. 22, 2015)
    • (2013) When Wearable Tech Makes You Smarter-by Zapping Your Brain
    • Statt, N.1
  • 43
    • 85054979052 scopus 로고    scopus 로고
    • accessed Jan. 25, 2015
    • http://www.foc.us/edge-tdcs-headset (accessed Jan. 25, 2015)
  • 44
    • 85049957608 scopus 로고    scopus 로고
    • May 28(accessed Jan. 25, 2015)
    • Halo Neuroscience-Press Release (May 28, 2014) http://haloneuro.com/press/ (accessed Jan. 25, 2015)
    • (2014) Halo Neuroscience-Press Release
  • 45
    • 85055006473 scopus 로고    scopus 로고
    • (accessed Jan. 25, 2015)
    • Halo Neuroscience, http://haloneuro.com/ (accessed Jan. 25, 2015)
    • Halo Neuroscience
  • 46
    • 85054987976 scopus 로고    scopus 로고
    • accessed Sep. 22, 2015
    • http://www.bloomberg.com/bw/articles/2014-10-08/thync-raises-13-million-for-its-brain-stimulatingelectrodes (accessed Sep. 22, 2015)
  • 47
    • 85055008478 scopus 로고    scopus 로고
    • accessed June 25, 2015
    • http://www.thync.com/science-and-technology (accessed June 25, 2015)
  • 48
    • 85055008523 scopus 로고    scopus 로고
    • (accessed Sep. 22, 2015)
    • US Food and Drug Administration, Regulatory Controls (Medical Devices), http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm (accessed Sep. 22, 2015)
    • Regulatory Controls (Medical Devices)
  • 49
    • 85055006946 scopus 로고    scopus 로고
    • accessed Sep. 22, 2015
    • https://www.federalregister.gov/articles/2014/06/12/2014-13756/neurological-deviceswithdrawal-of-proposed-effective-date-of-requirement-for-premarket-approval-for (accessed Sep. 22, 2015)
  • 50
    • 85054992031 scopus 로고    scopus 로고
    • https://www.federalregister. gov/articles/2014/09/22/2014-22453/reclassification-of-iontophoresis-devices-intended-for-any-otherpurposes
  • 51
    • 85054980176 scopus 로고    scopus 로고
    • accessed Jan. 25, 2015
    • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ PremarketSubmissions/PremarketApprovalPMA/ucm2007514.htm (accessed Jan. 25, 2015)
  • 52
    • 85054956695 scopus 로고    scopus 로고
    • 515 Program Initiative(accessed Sep. 22, 2015)
    • US Food And Drug Administration, 515 Program Initiative, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ CDRHTransparency/ucm240310.htm (accessed Sep. 22, 2015)
  • 53
    • 85055008913 scopus 로고    scopus 로고
    • accessed Sep. 22, 2015
    • http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm (accessed Sep. 22, 2015)
  • 54
    • 84882886851 scopus 로고    scopus 로고
    • The LegalDistinction in theUnited States Between a Cosmetic and a Drug
    • Peter Elsner & Howard I.Maibach eds
    • Peter BartonHutt, The LegalDistinction in theUnited States Between a Cosmetic and a Drug, inCOSMECEUTICALS 223, 240 (Peter Elsner & Howard I.Maibach eds., 2000)
    • (2000) COSMECEUTICALS , pp. 223-240
    • Hutt, P.B.1
  • 55
    • 85054982000 scopus 로고    scopus 로고
    • www.trans-cranial.com
  • 56
    • 85054987017 scopus 로고    scopus 로고
    • www.tDCSdevicekit.com
  • 58
    • 85055006173 scopus 로고    scopus 로고
    • Muse, http://www.choosemuse.com/
  • 59
    • 85054965961 scopus 로고    scopus 로고
    • Emotiv Insight, https://emotiv.com/insight.php
  • 60
    • 85054975836 scopus 로고    scopus 로고
    • Neurosky, http://neurosky.com/
  • 61
    • 85054965507 scopus 로고    scopus 로고
    • Melon http://www.thinkmelon.com/
  • 62
    • 85054965752 scopus 로고    scopus 로고
    • (accessedMarch 2015)
    • FocusBand http://www. ifocusband.com/ (accessedMarch 2015)
  • 64
    • 80052968691 scopus 로고    scopus 로고
    • A Systematic Review on Reporting and Assessment of Adverse Effects Associated with Transcranial Direct Current Stimulation
    • AndreRBrunoni et al., A Systematic Review on Reporting and Assessment of Adverse Effects Associated with Transcranial Direct Current Stimulation, 14 INT. J. NEUROPSYCHOPHARMACOL. 1133 (2011)
    • (2011) INT. J. NEUROPSYCHOPHARMACOL , vol.14 , pp. 1133
    • Brunoni, A.R.1
  • 65
    • 85054959469 scopus 로고    scopus 로고
    • accessed Feb. 26, 2015
    • http://www.fda.gov/RegulatoryInformation/Guidances/ucm209841.htm (accessed Feb. 26, 2015)
  • 66
    • 85054952678 scopus 로고    scopus 로고
    • accessed June 12, 2015
    • http://www.thync.com/resources/press-release/thync-launches-first-wearable-to-shift-your-state-of-mind (accessed June 12, 2015)
  • 67
    • 85009039926 scopus 로고
    • Intended Use and Medical Devices: Distinguishing Nonmedical Devices from Medical Devices under 21 USC 321(h)
    • Gary E. Gamerman, Intended Use and Medical Devices: Distinguishing Nonmedical Devices from Medical Devices under 21 USC 321(h), 61 GEO. WASH. L. REV. 806 (1993)
    • (1993) GEO. WASH. L. REV , vol.61 , pp. 806
    • Gamerman, G.E.1
  • 68
    • 85054976967 scopus 로고    scopus 로고
    • (accessedMar. 20, 2015)
    • US Food and Drug Administration, Bed Rail Safety: FDA and CPSC Activities, http://www.fda.gov/ MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ BedRailSafety/ucm362867.htm (accessedMar. 20, 2015)
    • Bed Rail Safety: FDA and CPSC Activities
  • 69
    • 0030229872 scopus 로고    scopus 로고
    • Butt Out!! Why the FDA Lacks Jurisdiction to Curb Smoking of Adolescents and Children
    • Margaret A. Boyd, Butt Out!! Why the FDA Lacks Jurisdiction to Curb Smoking of Adolescents and Children, 13 J. CONTEMP. HEALTH LAW POL'Y, 169 (1997)
    • (1997) J. CONTEMP. HEALTH LAW POL'Y , vol.13 , pp. 169
    • Boyd, M.A.1
  • 70
    • 85054983522 scopus 로고    scopus 로고
    • Acting Director, Office of Compliance, Food and Drug Administration, Warning Letter to Salton, Inc., July 12, 2000, (accessedMar. 15, 2015)
    • Steven D. Niedelman, Acting Director, Office of Compliance, Food and Drug Administration, Warning Letter to Salton, Inc., July 12, 2000, http://www.casewatch.org/fdawarning/ prod/2000/salton.shtml (accessedMar. 15, 2015)
    • Niedelman, S.D.1
  • 71
    • 85054958793 scopus 로고    scopus 로고
    • Compliance Offer, Aug. 11(accessedMar. 15, 2015)
    • William F. Defibaugh, Compliance Offer, Center for Devices and Radiological Health, Aug. 11, 2000, http://media.corporateir. net/media files/nys/sfp/salton rejuv.pdf (accessedMar. 15, 2015)
    • (2000) Center for Devices and Radiological Health
    • Defibaugh, W.F.1
  • 72
    • 85054995792 scopus 로고    scopus 로고
    • accessed Feb. 25, 2015
    • http://www.accessdata. fda.gov/cdrh docs/pdf/k011935.pdf (accessed Feb. 25, 2015)
  • 74
    • 85054970855 scopus 로고    scopus 로고
    • Raises $1.5 Million, TECH CRUNCH, May 1, 2014(accessed Feb. 25, 2015)
    • John Biggs, Halo, the Brain-Improving Wearable, Raises $1.5 Million, TECH CRUNCH, May 1, 2014, http://techcrunch.com/2014/05/01/halo-the-brain-improvingwearable-raises-1-5-million/ (accessed Feb. 25, 2015)
    • Halo, the Brain-Improving Wearable
    • Biggs, J.1
  • 75
    • 85049960659 scopus 로고    scopus 로고
    • June 28(accessed Feb. 1, 2015)
    • California Department of Public Health, CDPH Warns Consumers Not to Use TDCS Home Device Kit, June 28, 2013, http://www.cdph.ca.gov/Pages/NR13-029.aspx (accessed Feb. 1, 2015)
    • (2013) CDPH Warns Consumers Not to Use TDCS Home Device Kit
  • 76
    • 85054989079 scopus 로고    scopus 로고
    • accessed Sep. 22, 2015
    • http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM290787.pdf (accessed Sep. 22, 2015)
  • 77
    • 85054957752 scopus 로고    scopus 로고
    • accessed Jan. 25, 2015
    • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.85 (accessed Jan. 25, 2015)
  • 78
    • 84904789062 scopus 로고    scopus 로고
    • 79 Fed. Reg. 37,946 (July 3, 2014) to be codified at 21 C.F.R.(accessed Feb. 22, 2015)
    • US Food and Drug Administration, Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache, 79 Fed. Reg. 37,946 (July 3, 2014) to be codified at 21 C.F.R. 882,https://www.federalregister.gov/articles/2014/07/03/2014-15625/medical-devices-neurologicaldevices-classification-of-the-transcutaneous-electrical-nerve (accessed Feb. 22, 2015)
    • Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache , pp. 882
  • 79
    • 2942527770 scopus 로고    scopus 로고
    • (accessed Jan. 25, 2015)
    • Federal Trade Commission, FTC Policy Statement on Deception, http://www.ftc.gov/public-statements/ 1983/10/ftc-policy-statement-deception (accessed Jan. 25, 2015)
    • FTC Policy Statement on Deception
  • 80
    • 85054987962 scopus 로고    scopus 로고
    • accessed Jan. 20, 2015
    • http://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm (accessed Jan. 20, 2015)
  • 81
    • 0026489925 scopus 로고
    • Developing Standards for Health Claims-The FDA and the FTC
    • James Serafino, Developing Standards for Health Claims-The FDA and the FTC, 47 FOOD & DRUG L.J. 335, 335-337 (1992)
    • (1992) FOOD & DRUG L.J , vol.47
    • Serafino, J.1
  • 83
    • 85054971974 scopus 로고    scopus 로고
    • Press Release, Makers of Jungle Rangers Computer Game for Kids Settle FTC Charges that They Deceived Consumers with Baseless 'Brain Training' Claims, Jan. 20, 2015(accessed Feb. 26, 2015)
    • Federal Trade Commission, Press Release, Makers of Jungle Rangers Computer Game for Kids Settle FTC Charges that They Deceived Consumers with Baseless 'Brain Training' Claims, Jan. 20, 2015, http://www.ftc.gov/news-events/press-releases/2015/01/makers-jungle-rangers-computer-game-kidssettle-ftc-charges-they (accessed Feb. 26, 2015)
  • 84
    • 84876830326 scopus 로고    scopus 로고
    • Press Release, Sept. 8, 2011(accessed Jan. 8, 2015)
    • Federal Trade Commission, Press Release, 'Acne Cure' Mobile App Marketers Will Drop Baseless Claims Under FTC Settlements, Sept. 8, 2011, https://www.ftc.gov/news-events/press-releases/2011/ 09/acne-cure-mobile-app-marketers-will-drop-baseless-claims-under (accessed Jan. 8, 2015)
    • 'Acne Cure' Mobile App Marketers Will Drop Baseless Claims Under FTC Settlements
  • 85
    • 84953906240 scopus 로고    scopus 로고
    • Press Release Feb. 23(accessedMar. 1, 2015)
    • Federal Trade Commission, Press Release, FTC Cracks Down on Marketers of 'Melanoma Detection' Apps, Feb. 23, 2015, https://www.ftc.gov/news-events/press-releases/2015/02/ftc-cracks-down-marketers-melanomadetection-apps (accessedMar. 1, 2015)
    • (2015) FTC Cracks Down on Marketers of 'Melanoma Detection' Apps
  • 86
    • 85054980518 scopus 로고    scopus 로고
    • (accessed Jan. 25, 2015)
    • US Consumer Product Safety Commission, Products Under the Jurisdiction of Other Federal Agencies, http://www.cpsc.gov/en/Regulations-Laws-Standards/Products-Outside-CPSCs-Jurisdiction/ (accessed Jan. 25, 2015)
    • Products Under the Jurisdiction of Other Federal Agencies
  • 87
    • 85054957258 scopus 로고    scopus 로고
    • accessed Jan. 8, 2015
    • https://apps.fcc.gov/oetcf/eas/reports/ GenericSearch.cfm (accessed Jan. 8, 2015)
  • 88
    • 85054968632 scopus 로고    scopus 로고
    • (accessed Jan. 25, 2015)
    • US Food and Drug Administration, Radiation-Emitting Products-Cell Phones, http://www.fda.gov/radiationemittingproducts/ radiationemittingproductsandprocedures/homebusinessandentertainment/cellphones/ default.htm (accessed Jan. 25, 2015)
    • Radiation-Emitting Products-Cell Phones
  • 89
    • 85054961825 scopus 로고    scopus 로고
    • Coverage of Personal Importations(accessed Jan. 10, 2015)
    • US Food and Drug Administration, Regulatory Procedures Manual, 9-2, Coverage of Personal Importations, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179266.htm (accessed Jan. 10, 2015)
    • Regulatory Procedures Manual , vol.9 , Issue.2
  • 90
    • 85054976365 scopus 로고    scopus 로고
    • (accessed Jan. 15, 2015)
    • Council ofBetter Business Bureaus,Mission andVision, http://www.bbb.org/council/about/vision-missionand-values/ (accessed Jan. 15, 2015)
  • 91
    • 85054973728 scopus 로고    scopus 로고
    • June 24 (accessed Jan.10, 2015)
    • Maureen K. Ohlhausen, Remarks at the BBB Self-Regulation Conference, June 24, 2014, at 2, http://www.ftc.gov/system/ files/documents/public statements/410391/140624bbbself-regulation.pdf (accessed Jan.10, 2015)
    • (2014) Remarks at the BBB Self-Regulation Conference , pp. 2
    • Ohlhausen, M.K.1
  • 92
    • 85054957937 scopus 로고    scopus 로고
    • accessed Jan. 25, 2015
    • http://www.bbb. org/greater-san-francisco/business-reviews/home-electronics/european-engineers-limited-in-redwoodcity-ca-459140/complaints (accessed Jan. 25, 2015)
  • 93
    • 85054968671 scopus 로고    scopus 로고
    • (accessed Jan. 25, 2015)
    • National Advertising Division, http://www.bbb.org/council/the-national-partner-program/nationaladvertising-review-services/national-advertising-division/ (accessed Jan. 25, 2015)
  • 94
    • 85010858349 scopus 로고    scopus 로고
    • Buttressing Regulation of Cognitive Enhancement Devices with Principles of Harm Reduction
    • Nicholas S. Fitz & Peter B. Reiner, Buttressing Regulation of Cognitive Enhancement Devices with Principles of Harm Reduction, 1 J. L. BIOSCI. 322 (2014)
    • (2014) J. L. BIOSCI , vol.1 , pp. 322
    • Fitz, N.S.1    Reiner, P.B.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.