Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

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Index for References

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Ref 11 George In Vitro Mechanisms of Cell Proliferation Induction Induction A Novel Bioactive Treatment for Accelerating Wound Healing Wounds 14 p 107 115

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Ref 2 Jones Electromagnetic field interference and cardiac pacemakers Jones S L Electromagnetic Field Interference and Cardiac Pacemakers Physical Therapy 56 9 p 1013 1018 1976

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Ref 1 Inrich W J M de Bakker and H J Bisping Electromagnetic interference in implantable pacemakers in Implantable Pacemakers Pacing and Clinical Electrophysiology 1 1 p 52 61 1978

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Ref 10 Martin C J et al An Evaluation of Radiofrequency Exposure From Therapeutic Diathermy Equipment in the Light of Current Recommendations Clinical Physics and Physiological Measurement 11 1 p 53 63

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Ref 12 Elliott Bennett Guerrero et al Gentamicin Collagen Sponge for Infection Prophylaxis in Colorectal Surgery New England Journal of Medicine 363, no. 11 1038 1049 2010

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Ref 13 Kaplan Aaron V et al Medical Device Development: From Prototype to Regulatory Approval Circulation 109 no 25 3068 3072

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Ref 14 Lionberger FDA Critical Path Initiatives Opportunities for Generic Drug Development

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Ref 15 Makower Joshua FDA Impact on US Medical Technology Innovation A Survey of Over 200 Medical Technology Companies

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Ref 16 Geiger Dale R FY 2003 and FY 2004 Unit Costs for the Process of Medical Device Review

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Ref 17 U.S. Small Business Administration, "Table of Small Business Size Standards Matched to North American Industry

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Ref 3 Murray C C S Kitchen Effect of Pulse Repetition Rate on the Perception of Thermal Sensation With Pulsed Shortwave Diathermy Physiotherapy Research International 52 p 73 84 2000

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Ref 4 Erdman W J Peripheral Blood Flow Measurements During Application of Pulsed High Frequency Currents American Journal of Orthopedics 8 p 196 197 1960

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Ref 5 Ruggera P S et al In Vitro Assessment of Tissue Heating Near Metallic Medical Implants by Exposure to Pulsed Radio Frequency Diathermy Physics in Medicine and Biology 48 17 p 2919 2928 2003

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Ref 6 FDA Summary Minutes Meeting of the Circulatory System Devices Advisory Panel Center for Devices and Radiological Health Gaithersburg Holiday Inn, Gaithersburg MD available at

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Ref 7 FDA Patient Safety News, Show 13 Warning on Diathermy and Implanted Leads

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Ref 8 Kloth L et al Therapeutic Microwave and Shortwave Diathermy A Review of Thermal Effectiveness, Safe Use, and State of the Art HHS Publication FDA 85 8237 1984

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Ref 9 Shields N N O Hare and J Gormley An Evaluation of Safety Guidelines to Restrict Exposure to Stray Radiofrequency Radiation From Short Wave Diathermy Units Physics in Medicine and Biology 49 13 p 2999 3015 2004