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Requirement for Premarket Approval for Cranial Electrotherapy Stimulator

Document ID: FDA-2011-N-0504-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices, Neurological Devices
Federal Register Number: 2011-19957
CFR Citation: 21 CFR Part 882
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: August 08 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 48062 - 48070
Page Count: 9
Comment Start Date: August 8 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 7 2011, at 11:59 PM Eastern Standard Time

Attachments:

List of References

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Reference 1 - A Pilot Study of Cranial Electrotherapy Stimulation for Generalized Anxiety Disorder

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Reference 10 - Premarket Notifications: The First 24,000

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Reference 11 - GDP Deflator

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Reference 12 - FY 2003 and FY 2004 Unit Costs for the Process of Medical Device Review

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Reference 2 - The Effect of a Single CES on Multiple Stress Measures

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Reference 3 - CES in Patients Suffering from Acute Anxiety Disorders

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Reference 4 - Investigation of Effectiveness of CES in Treatment of Anxiety Disorders Among Outpatient Psychiatric Patients, Impulse Control Parolees and Pedophiles

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Reference 5 - The Effect of CES on Preoperative Anxiety and Hemodynamic Responses

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Reference 6 - CES - A Safe and Effective Low Cost Means of Anxiety Control in a Dental Practice

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Reference 7 - Meta-analysis of CES in Relation to the Primary and Secondary Symptoms of Subsstance Withdrawal

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Reference 8 - Meta-analysis of Randomized Controlled Trials of Cranial Electrostimulation

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Reference 9 - Manta: Vital Info on Small Businesses

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Comments

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Total: 171
Helen M. Sherry, Ph.D. - Comment
Posted: 08/24/2011     ID: FDA-2011-N-0504-0005

Nov 07,2011 11:59 PM ET
Academy of Clinical Sleep Disorders Disciplines - Comment
Posted: 08/24/2011     ID: FDA-2011-N-0504-0006

Nov 07,2011 11:59 PM ET
Lori R. Grifo, Of Sound Mind, Inc. - Comment
Posted: 08/24/2011     ID: FDA-2011-N-0504-0007

Nov 07,2011 11:59 PM ET
Kathy Platoni, Psy. D. - Comment
Posted: 08/24/2011     ID: FDA-2011-N-0504-0008

Nov 07,2011 11:59 PM ET
Robert E. McCarthy, Ph.D., McCarthy Counseling Associates, PA and The Center for Psychophysiological Assessment and Treatment - Comment
Posted: 08/24/2011     ID: FDA-2011-N-0504-0009

Nov 07,2011 11:59 PM ET

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