• 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
Recognition List Number: 038 FR Publication Date: 01/27/2015 

Part B: Supplementary Information

Recognition Number 13-72: IEEE Std 11073-10425-2014 , health informatics - personal health device communication, part 10425: device specialization - continuous glucose monitor (cgm) . (Software/Informatics)

Date of Standard: 2014. 
Address of Standards Development Organization:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
Devices Affected:
Continuous Glucose Monitors
Processes Affected:
PMA, IDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Sensor, Glucose, Invasive Class 3 MDS
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
 Naomi R Schwartz
  FDA/OMPT/CDRH/OIR
  10903 New Hampshire Avenue WO66 RM4613
  Silver Spring MD 20993
  301/796-2645
  email: naomi.schwartz@fda.hhs.gov
-
-