Recognition List Number: 030 Publication Date: 01/15/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-36: ISO 8009:2004(E):, Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests. (ObGyn/Gastroenterology)
Date of Standard: 2004. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Vaginal Contraceptive Diaphragms |
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| Processes Affected: |
| 510(k), Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard with the exception of Section 11.2.1, regarding symbols used in labeling.
NOTE: Labeling requirements for contraceptive diaphragms are also governed by 21 CFR 801. For example, diaphragm labeling should contain warnings *that diaphragms carry the risk of menstrual TSS * that nonoxynol-9 in spermicidal jelly used with the diaphragm can be an irritant and may increase the risk of HIV acquisition *that diaphragms do not protect against STDs. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5350 |
Diaphragm, Contraceptive (And Accessories) |
Class 2 |
HDW |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contacts: |
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| 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 |
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