General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products

Document ID: FDA-2013-N-0461-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-10982
CFR Citation: 21 CFR Part 878
View Document:  View as format pdf View as format html

Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: May 09 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 27117 - 27124
Page Count: 8
Comment Start Date: May 9 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 7 2013, at 11:59 PM Eastern Standard Time

Attachments:

Ref 1 Knight J M A N Kirincich E R Farmer et al Awareness of the Risks of Tanning Lamps Does Not Influence Behavior Among College Students Archives of Dermatology

View Attachment:

Ref 10 Sivamani R K L A Crane R P Dellavalle et al The Benefits and Risks of Ultraviolet Tanning and Its Alternatives The Role of Prudent Sun Exposure Dermatologic Clinics

View Attachment:

Ref 11 Cadet J E Sage and T Douki Ultraviolet Radiation Mediated Damage to Cellular DNA Mutation Research

View Attachment:

Ref 12 Fitzpatricks Dermatology in General Medicine 7th ed p 999 Columbus OH McGraw Hill 2008

View Attachment:

Ref 13 Ibid p 814

View Attachment:

Ref 14 Ibid p 1135

View Attachment:

Ref 15 Salama A K N de Rosa R P Scheri et al Hazard-Rate Analysis and Patterns of Recurrence in Early Stage Melanoma Moving Towards a Rationally Designed Surveillance Strategy PLoS One

View Attachment:

Ref 16 Niendorf K B and H Tsao Cutaneous Melanoma Family Screening and Genetic Testing Dermatologic Therapy

View Attachment:

Ref 17 Nole G and A Johnson An Analysis of Cumulative Lifetime Solar Ultraviolet Radiation Exposure and the Benefits of Daily Sun Protection Dermatologic Therapy

View Attachment:

Ref 18 Reed K B J D Brewer C M Lohse et al Increasing Incidence of Melanoma Among Young Adults An Epidemiological Study in Olmsted County Minnesota Mayo Clinic Proceedings vol. 87, pp. 328–334 2012

View Attachment:

Ref 19 Cust A E B K Armstrong C Goumas et al Sunbed Use During Adolescence and Early Adulthood Is Associated With Increased Risk of Early Onset Melanoma International Journal of Cancer

View Attachment:

Ref 2 Lam R W A Buchanan J A Mador et al The Effects of Ultraviolet A Wavelengths in Light Therapy for Seasonal Depression,’’ Journal of Affective Disorders

View Attachment:

Ref 20 Bleyer A and R Barr Cancer in Young Adults 20 to 39 Years of Age Overview Seminars in Oncology

View Attachment:

Ref 21 Beasley M T0 and B S Kittel Factors That Influence Health Risk Behaviors Among Tanning Salon Patrons Evaluation the Health Profession

View Attachment:

Ref 22 Autier P and P Boyle Artificial Ultraviolet Sources and Skin Cancers Rationale for Restricting Access to Sunbed Use Before 18 years of Age Nature Reviews Clinical Oncology

View Attachment:

Ref 23 IARC Working Group on Artificial Ultraviolet Light UV and Skin Cancer The Association of Use of Sunbeds With Cutaneous Malignant Melanoma and Other Skin Cancers A Systematic Review International Journal of Cancer

View Attachment:

Ref 24 National Conference of State Legislatures‘Indoor Tanning Restrictions for Minors—A State by State Comparison Updated April 2013

View Attachment: View as format pdf

Ref 25 Pawlak M T M Bui M Amir et al Legislation Restricting Access to Indoor Tanning Throughout the World Archives of Dermatology

View Attachment:

Ref 26 Walters B L and T M Kelley Commercial Tanning Facilities A New Source of Eye Injury The American Journal of Emergency Medicine

View Attachment:

Ref 27 Vajdic C M A Kricker M Giblin et al Artificial Ultraviolet Radiation and Ocular Melanoma in Australia International Journal of Cancer

View Attachment:

Ref 28 Stapleton, J L J Hillhouse R Turrisi et al Erythema and Ultraviolet Tanning Findings From a Diary Study Translational Behavioral Medicine

View Attachment:

Ref 29 Cokkinides V M Weinstock D Lazovich et al Indoor Tanning Use Among Adolescents in the United States 1998 2004 Cancer

View Attachment:

Ref 3 Lee T M C C Chan J G Paterson et al Spectral Properties of Phototherapy for Seasonal Affective Disorder A Meta Analysis Acta Psychiatrica Scandinavica

View Attachment:

Ref 30 Fitzpatricks Dermatology in General Medicine 7th ed p 828 Columbus OH McGraw Hill 2008

View Attachment:

Ref 31 Ibid p 57

View Attachment:

Ref 32 Ibid p 2353

View Attachment:

Ref 33 Fisher G J S Kang J Varani et al Mechanisms of Photoaging and Chronological Skin Aging Archives of Dermatology

View Attachment:

Ref 34 Quan T Z Qin W Xia et al Matrix Degrading Metalloproteinases in Photoaging Journal of Investigatory Dermatology Symposium Proceedings

View Attachment:

Ref 35 Helmus M N D F Gibbons and D Cebon Biocompatibility Meeting a Key Functional Requirement of Next Generation Medical Devices Toxicologic Pathology

View Attachment:

Ref 36 Olson W H Electrical Safety Medical Instrumentation Application and Design 4th ed Webster J G ed Hoboken NJ Wiley 2009

View Attachment:

Ref 37 FDA 2010 Meeting materials including presentations a meeting transcript and meeting summary

View Attachment: View as format pdf

Ref 38 FDA Executive Summary

View Attachment: View as format pdf

Ref 39 Autier P J F Dore F Lejeune et al Cutaneous Malignant Melanoma and Exposure to Sunlamps or Sunbeds An EORTC Multicenter Case Control Study in Belgium France and Germany EORTC Melanoma Cooperative Group International Journal of Cancer

View Attachment:

Ref 4 Devgun M S B E Johnson and C R Paterson Tanning Protection Against Sunburn and Vitamin D Formation With a UV A Sun Bed British Journal of Dermatology

View Attachment:

Ref 40 Berwick M Are Tanning Beds Safe Human Studies of Melanoma Pigment Cell Melanoma Research

View Attachment:

Ref 41 Boyd A S Y Shyr and L E King Jr Basal Cell Carcinoma in Young Women An Evaluation of the Association of Tanning Bed Use and Smoking Journal of the American Academy of Dermatology

View Attachment:

Ref 42 Clough Gorr K M L Titus Ernstoff A E Perry et al Exposure to Sunlamps Tanning Beds and Melanoma Risk Cancer Causes Control

View Attachment:

Ref 43 El Ghissassi F R Baan K Straif et al A Review of Human Carcinogens Part al A Review of Human Carcinogens Part D Radiation WHO International Agency for Research on Cancer Monograph Working Group Lancet Oncology

View Attachment:

Ref 44 Gallagher R P J J Spinelli and T K Lee Tanning Beds Sunlamps and Risk of Cutaneous Malignant Melanoma Cancer Epidemiology Biomarkers Prevention

View Attachment:

Ref 45 Geller A C D R Brooks G A Colditz et al Sun Protection Practices Among Offspring of Women With Personal or Family History of Skin Cancer Pediatrics

View Attachment:

Ref 46 Goodhead D T Initial Events in the Cellular Effects of Ionizing Radiations Clustered Damage in DNA International Journal of Radiation Biology

View Attachment:

Ref 47 Han J G A Colditz and D J Hunter Risk Factors for Skin Cancers A Nested Case Control Study Within the Nurses Health Study International Journal of Epidemiology,

View Attachment:

Ref 48 Harrison S L R MacLennan and P G Buettner Sun Exposure and the Incidence of Melanocytic Nevi in Young Australian Children Cancer Epidemiology Biomarkers Prevention

View Attachment:

Ref 49 Karagas M R V A Stannard L A Mott et al Use of Tanning Devices and Risk of Basal Cell and Squamous Cell Skin Cancers. Journal of the National Cancer Institute

View Attachment:

Ref 5 Woo D K and M J Eide Tanning Beds Skin Cancer and Vitamin D An Examination of the Scientific Evidence and Public Health Implications Dermatologic Therapy

View Attachment:

Ref 50 Lever L R and C M Lawrence Nonmelanoma Skin Cancer Associated With Use of a Tanning Bed New England Journal of Medicine

View Attachment:

Ref 51 Parr C L A Hjartaker P Laake et al Recall Bias in Melanoma Risk Factors and Measurement Error Effects A Nested Case Control Study Within the Norwegian Women and Cancer Study American Journal of Epidemiology

View Attachment:

Ref 52 Ting W K Schultz N N Cac et al Tanning Bed Exposure Increases the Risk of Malignant Melanoma International Journal of Dermatology

View Attachment:

Ref 53 Westerdahl J H Olsson A Masback et al Use of Sunbeds or Sunlamps and Malignant Melanoma in Southern Sweden American Journal of Epidemiology

View Attachment:

Ref 6 National Institutes of Health Office of Dietary Supplements ‘Dietary Supplement Fact Sheet Vitamin D

View Attachment: View as format pdf

Ref 7 World Health Organization Sunbeds Tanning and UV Exposure

View Attachment: View as format pdf

Ref 8 Giovannucci E Y Liu E B Rimm et al Prospective Study of Predictors of Vitamin D Status and Cancer Incidence and Mortality in Men Journal of the National Cancer Institute

View Attachment:

Ref 9 Cannell J J B.W. Hollis M Zasloff et al Diagnosis and Treatment of Vitamin D Deficiency Expert Opinion in Pharmacotherapy

View Attachment:

References List

View Attachment: View as format pdf

Comments

    View All
Total: 189
Sunlamp Products - Comment
Posted: 07/01/2013     ID: FDA-2013-N-0461-0182

Aug 07,2013 11:59 PM ET
Richard Harvey Bonder - Comment
Posted: 06/06/2013     ID: FDA-2013-N-0461-0067

Aug 07,2013 11:59 PM ET
Gopal Patel - Comment
Posted: 06/21/2013     ID: FDA-2013-N-0461-0142

Aug 07,2013 11:59 PM ET
Jeffrey M Scricca MD - Comment
Posted: 06/21/2013     ID: FDA-2013-N-0461-0112

Aug 07,2013 11:59 PM ET
HARRISON R MCDONALD - Comment
Posted: 06/21/2013     ID: FDA-2013-N-0461-0124

Aug 07,2013 11:59 PM ET

Related Documents

    More
Total: 6