Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-54: ASTM D6976-08, Standard Specification for Rubber Contraceptives - Vaginal Diaphragms. (ObGyn/Gastroenterology)
Date of Standard: 2008. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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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: |
| National, Vertical |
| Extent of Recognition: |
Complete standard
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 spermicidial 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 Contact: |
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