Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-371: USP 35-NF30:2012, Biological Indicator for Steam Sterilization - Self Contained. (Sterility)
Date of Standard: 2012. |
| Address of Standards Organization: |
| United States Pharmacopeial Convention, Inc. (USP) |
| 12601 Twinbrook Parkway |
| Rockville, MD 20852 |
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| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
| Biological indicators for monitoring steam sterilization processes |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.2800 |
Indicator, Biological Sterilization Process |
Class 2 |
FRC |
| |
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| Relevant Guidance: |
USP 35-NF30:2012, <55> Biological Indicators - Resistance Performance Tests
USP 35-NF30:2012, <1035> Biological Indicators for Sterilization
Guidance for Industry and FDA Staff; Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007 |
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| FDA Technical Contacts: |
| Cesar Perez, Ph.D. |
| FDA/CDRH/OC |
| 10903 New Hampshire Avenue Building 66, Room 1561 |
| Silver Spring MD 20993 |
| 301/796-5476 |
| Email: cesar.perez@fda.hhs.gov |
|
| Geetha C. Jayan, M.V.Sc, Ph.D |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5400 |
| Silver Spring MD 20993 |
| 301/796-6300 |
| Email: geetha.jayan@fda.hhs.gov |
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