510(k) Timing from Submittal to FDA Approval

C

chodson1

How long does it take (from submittal to approval) for the FDA to approve a 510K? I would like to hear some real life timing resutls from those that have submitted 510k's to the FDA recently.

Thanks,

Chad
 
C

chodson1

Re: 510K timing

Wow, nine months for approval. What class was the device? I am interested in class II devices specifically.
 
K

kvrad

Re: 510K timing

I would highly suggest using the 3rd party review process if possible. We just put through a Class II device that was cleared in 17 days. Great process if your device is eligible.:D
 
M

MIREGMGR

Re: 510K timing

A conventional 510(k) submission directly to the FDA, for which there are no requests for additional information or other process-clock-stopping interactions, will take almost 90 days.

See this FDA guidance.
 
Last edited by a moderator:
F

fvsanchez

Re: 510K timing

I would highly suggest using the 3rd party review process if possible. We just put through a Class II device that was cleared in 17 days. Great process if your device is eligible.:D

KVRAD - would like more details as to how you accomplished this for a Class II device. Our device that is going to be filed is a new version of an already approved device and we are a small business. Thanks for your reply, we would love to achieve anywhere near this time, customers are hungry for the revised version.:thanx:
 

Ronen E

Problem Solver
Moderator
Re: 510K timing

KVRAD - would like more details as to how you accomplished this for a Class II device. Our device that is going to be filed is a new version of an already approved device and we are a small business. Thanks for your reply, we would love to achieve anywhere near this time, customers are hungry for the revised version.:thanx:

Sounds like you may qualify for a special 510(k) - device modification. That may shorten the timeline.

Good luck,
Ronen.
 
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