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510(k) review timeline

Ashley Fu

Starting to get Involved
#1
We have sent a 510(k) submission by post on 14, July 2020. But we haven't received any other email except an acknowledgement letter until now. Today is almost the 100th day!

The most possibility reason I thought is the Covid-19 that disturb the review timeline. what is your opinion?
 
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shimonv

Trusted Information Resource
#2
I recommend that you contact FDA. I know from a recent case that FDA did issue a response but that somehow it was not received by the company.
 

mihzago

Trusted Information Resource
#3
By acknowledgement letter do you mean a letter stating that your submission was received, booked and assigned a K number?
You should have had received another letter from your lead reviewer confirming that your submission passed the administrative review. If you did, then contact your lead reviewer and ask politely where things are.

I have not heard of any significant delays with submissions (only pre-subs), but still you should have received some feedback by now.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
We also had a similar experience but received feedback the 59th day of review under the deadline. With COVID its possible they cant meet these deadlines so its tough to assume anything. Contact the lead reviewer.
 

Ashley Fu

Starting to get Involved
#6
By acknowledgement letter do you mean a letter stating that your submission was received, booked and assigned a K number?
You should have had received another letter from your lead reviewer confirming that your submission passed the administrative review. If you did, then contact your lead reviewer and ask politely where things are.

I have not heard of any significant delays with submissions (only pre-subs), but still you should have received some feedback by now.
Yes, the submission was received and a K number is assigned. BUT the letter about whether our submission had passed the RTA review wasn't received. Too much time has wasted! Can't imagine what consequence could be!
 
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