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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 9-68: ISO 23409 First edition 2011-02-15, male condoms - requirements and test methods for condoms made from synthetic materials. (ObGyn/Gastroenterology)

Date of Standard: 2011. 
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)
DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Male Condoms made from Synthetic Materials
Processes Affected:
510(k), IDE, Design Control Input, QSR
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard, with the following comments and exceptions:

Annex J.3 Testing for holes, Electrical test is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§884.5300 Condom, Synthetic Class 2 MOL
Relevant Guidance:
Testing Guidance for Male Condoms made from New Material (Non-Latex), DRAFT: June 29, 1995.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080618.htm

Compliance Policy Guide and FDA Test Methods (Sub Chapter 345 Obstetrics and Gynecology (Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure (CPG 7124.21) (revised December 22, 2009)

Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms Document (issued on: July 11, 2008)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070731.htm
FDA Technical Contacts:
 Sharon Andrews
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G110
  Silver Spring MD 20993
  301/796-6529
  email: sharon.andrews@fda.hhs.gov
 Elaine Blyskun
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G202
  Silver Spring MD 20993
  301/796-6533
  email: elaine.blyskun@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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