Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
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Questions on CLIA (Clinical Laboratory Improvement Amendments) waived letter
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redknight07
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Unique Device Identifier for Software Medical Device
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3
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ryno fan
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Importance of Medical Device Accessory Design Controls
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4
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evilchilli_420
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Major Revision to FDA Adverse Event Reporting
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Tonyw
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Will this application require 510k or not ?
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Tonyw
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Unnecessary Modification Clinical Evaluation 510(k)
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2
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Tonyw
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Software Medical Device Bug Fixes: Correction or Corrective Action?
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5
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5K
Sidney Vianna
Sidney Vianna
sagai
Unified Device Identification Final Rule is out - September 2013
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13
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ScottDL
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UDI: HIBCC vs. GS1 - Recommendations regarding which one to select
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2
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Ajit Basrur
Ajit Basrur
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Adverse Event Reporting Flowchart (US) - feedback appreciated!
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4
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4K
yodon
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Can I consider My medical Application as MDDS ?
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1
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sagai
sagai
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Device regulation document for medical application
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2
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kingkobra
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  • Locked
Regulation Process for Add on Accessory to an Existing Medical Device
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1
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6K
J0anne
J0anne
sagai
Mobile Medical Applications Final Guidance Released
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0
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sagai
sagai
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FDA Acceptance of ISO 13485 Reports from a Recognized International Program
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4
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MIREGMGR
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