Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

 
Docket ID: FDA-2011-D-0453
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: FDA-2016-D-2021
Short Title: Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device
Keyword(s): cdrh20116, Change to an Existing Device, 510(k) Monidfications
Type: Nonrulemaking
Docket Status: OPEN
Center: CDRH
Docket Item Code: D
 

Primary Documents

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Comment Now!
Due Nov 07, 2016 11:59 PM ET
Notice
Posted: 08/08/2016
ID: FDA-2011-D-0453-0043
Comment Period Closed
Nov 28, 2011 11:59 PM ET
Notice
Posted: 11/08/2011
ID: FDA-2011-D-0453-0026
Comment Period Closed
Oct 25, 2011 11:59 PM ET
Notice
Posted: 07/27/2011
ID: FDA-2011-D-0453-0001

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 11/04/2011
ID: FDA-2011-D-0453-0008

Comments

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39
Comments Received*
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