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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 12-194
Standard
ANSI HPS  N43.6-2007 (R2013)
Sealed Radioactive Sources - Classification
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.5730 Radionuclide brachytherapy source.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry-Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources. Document Issued on August 2, 2000

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Robert A. Phillips
  FDA/OMPT/CDRH/OSEL/DIDSR/CONT/
  301-796-2787
  roberta.phillips@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
HPS Health Physics Society http://hps.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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