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Index of CDRH Web Documents

KEY: Links are numbered according to what type of file they point to. 1=Text, 2=PDF, 3=PowerPoint, 4=Word, 5=XML, 6=See Also. Topics starting with : 0-9  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z 
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Some additional items of interest can be found on the Consumer Information page.
 
N H R I C
* National Health Related Items Code - NHRIC [Text]
 
Needles
* Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes [Text] [PDF]
* Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles [Text]
* Needle Status Reclassification [Text]
* Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers [Text] [PDF]
* NeedleZap [Text]
* Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA [Text] [PDF]
* Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy   [PDF]
* Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA [Text] [PDF]
 
Neonatal
* Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final [Text] [PDF]
 
Neurological Shunts
* Shunt Technology: Challenges and Emerging Directions   [PDF]
 
Nitric Oxide / Nitrogen Dioxide
* Breath Nitric Oxide Test System - Class II Special Controls Guidance Document [Text] [PDF]
 
Non-Diagnostic Medical Devices
* Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices [Text]
 
Nondisclosure
* Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo) [Text]
 

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