|Recognition List Number: 027 FR Publication Date: 08/02/2011
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 |
|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) |
|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
NOTE: Toxicity testing. The condom should also be tested for acute systemic toxicity, 90-day muscle implantation, and genotoxicity. Genotoxicity testing should consist of three tests including a test for gene mutation in bacteria, an in vitro test with cytogenetic evaluation of chromosomal damage with mammalian cells or an in vitro mouse lymphoma tk assay, and an in vivo test for chromosomal damage using rodent hematopoietic cells. Refer to FDA?s 1995 guidance document.
Personal Lubricants. Manufacturers should evaluate the effect of common personal lubricants on important condom properties. The test method should include different types of lubricants, e.g., water-based, silicone-based, glycol-based. By way of reference, refer to FDA?s SIS for ASTM D7661-10. Condom labeling should reflect findings from this testing.
Clinical Study. This standard calls for a randomized controlled study, comparing slippage and breakage of the synthetic condom and a condom made from natural rubber latex. The normative requirement allows for a difference of 2.5% for total failure (confidence interval approach). However, the study report should also provide the individual rates for slippage and
breakage, as well as non-inferiority margins. Depending on the study results, mitigating labeling may be necessary.
Clause 13, Stability and shelf-life. The following condom properties should also be evaluated, following accelerated and real-time aging:
* tensile strength
* tear resistance and propagation
NOTE: Freedom from Holes. The FDA does not recognize the electrical method of testing for holes in condoms made of synthetic materials. Currently, the water leak test method is the recognized method. The FDA referee testing for water leakage (freedom from holes) is intended to follow the current FDA Compliance Policy Guide, sec. 345.100 Condoms: Defects - Criteria for Direct Reference Seizure (CPG 7124.21) and methodology comparable to the hang-and-roll method described in Annex J of ISO 23409 Male Condoms ? Requirements and Test Methods for Condoms made from Synthetic Materials
|Related CFR Citations and Product Codes:|
|Relevant Guidance: |
|Testing Guidance for Male Condoms made from New Material (Non-Latex), DRAFT: June 29, 1995.
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300. Document issued December 23, 2008.
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
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide Document issued on: January 5, 2009. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070589.htm
|FDA Technical Contact:|
| Colin M. Pollard |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G108 |
| Silver Spring MD 20993 |
| 301/796-6537 |
| email: firstname.lastname@example.org|
|* 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 |