Order for Certain Class III Devices; Submission of Safety and Effectiveness Information

 
Docket ID: FDA-2009-M-0101
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Docket contains confidential material
Docket Details open glossary dialog  
Related RINs: 0910-AG29
Related Dockets: None
Short Title: Order for Certain Class III Devices; Submission of Safety and Effectiveness Information
Keyword(s): cdrh20092, medical devices, CDRH, 515(i)
Type: Nonrulemaking
Docket Status: OPEN
Center: CDRH
Docket Item Code: M
 

Primary Documents

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Comment Period Closed
Aug 07, 2009 11:59 PM ET
Notice
Posted: 04/09/2009
ID: FDA-2009-M-0101-0001
Comment Period Closed
Other
Posted: 01/29/2015
ID: FDA-2009-M-0101-0123
Comment Period Closed
Other
Posted: 09/19/2014
ID: FDA-2009-M-0101-0121
Comment Period Closed
Other
Posted: 09/19/2014
ID: FDA-2009-M-0101-0122

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 07/08/2012
ID: FDA-2009-M-0101-0051
Comments Not Accepted
Supporting & Related Material
Posted: 12/12/2011
ID: FDA-2009-M-0101-0029
Comments Not Accepted
Supporting & Related Material
Posted: 12/12/2011
ID: FDA-2009-M-0101-0033

Comments

View All  (87)

171
Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.