• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 13-80
Standard
IEEE Std 11073-20601:2014
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol [including Corrigendum 1 (2015)]
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
FDA Technical Contacts
 Sandy Weininger
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
 Catherine Li
  FDA/OMPT/CDER/OTS/OCS/
  301-796-6304
  catherine.li@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
-
-