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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 5-40: ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices. (General I (QS/RM))

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
All medical devices
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
FDA Technical Contact:
 Melissa Torres
  FDA/CDRH/OC
  10903 New Hampshire Avenue Building 66, Room 2640
  Silver Spring MD 20993
  301/796-5576
  email: melissa.torres@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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