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DHF Review - When does the FDA review the DHF?

D

divyaganapathy

#1
When does the FDA review the DHF? Does the sponsor need to submit the DHF in case of 510K premarket notification for class IIa and IIb?
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
There are no US FDA class IIa and IIb...only Class II.

You never submit your DHF in entirety to US FDA. You retain it, and if they inspect you they are likely to review it onsite. It's also your central information repository for collating information that you do submit with a marketing-authorization application.
 
S

Sybarite

#4
BTW, your DHF should be complete prior to submission of the 510k. I hope that your question was not intended to identify your "deadline" for completing your DHF.
 
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