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Contacting FDA via phone to let them know a Submission is Imminent

E

ElmerF

#1
I will be submitting a 510K shortly. Is there any necessity (or point for that matter) in contacting the fda via phone to let them know a submission is imminent. We do not qualify for any of the special pre-meetings (ie no clinical trial, no novel design/material) and their telephone guidelines seem to want to limit telephone contact as much as possible. At the submission stage the reviewer will not yet have been assigned. There has been a lot of buzz about contacting FDA early and often. I have only ever looked at this in the light of PMAs, HDEs etc but not 510Ks but there is some expectation from upper management that some sort of conversation will take place. Can anyone who has been through this process recently weigh in here. I would really appreciate it?
 
M

MIREGMGR

#2
There is no need, or functional role, for such a notification for a 510(k). The arrival of the submission serves as the notification of initiation of the process.

Verbal interaction with FDA is most useful in regard to field actions, i.e. "recalls". My view is that it's appropriate to contact the Recall Coordination Officer in your regional FDA office whenever the possibility of a field action arises, to give them a heads-up. Ultimately the Recall Coordinator will decide whether a field action is legally a Recall, subject to FDA supervision. Since it's almost always to your benefit to not have a field action become a Recall, it's potentially helpful to make sure that the Recall Coordinator is fully informed as early as possible of your analysis of the risks and the actions you're taking to manage those risks.
 
#3
I would submit & wait for the acknowledgment letter, then follow up with a phone call later on if desire/needed once you have your unique tracking number for your submission, i.e., K#sequencial number & reviewer name assigned to your device.

FDA eSubmitter: Turbo 510(k) electronic submission
Frequently Asked Questions on eSubmitter and OIVD
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107780.htm

510(k) Premarket Notification Submission Process
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

View the 510(k) Process Video (Windows Media Video)
http://www.accessdata.fda.gov/videos/cdrh/510K.asx
 

Attachments

#4
Electronic Copies for Pre-Market Submissions
General Information - Questions and Answers
http :// www. fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED


eSubmitter Tutorial Videos
eSubmitter Tutorial Videos
 
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D

devicenewbie

#5
Hi All,

I am new to the game. I have submitted a 510(k) which has been refused for administrative reasons. This is the third time (UUGH). I have contacted the reviewer with my proposed changes but have not heard anything back. I have called an left messages with no success.

Does anyone have any advice for me? What is the best way to get them to respond in a timely manner?
 
M

MIREGMGR

#6
I for one don't know. I've succeeded in speaking with a reviewer before via direct phone contact, but other times not. My recent experience has been that emails are very slow to be responded to.

If you're in a difficult-timeline situation, i.e. your 510(k) process is holding up significant revenues so that you could tolerate higher costs to get clearance faster, you could consider talking to a third party 510(k) reviewer that could take over the process and work with you to achieve expeditious clearance.
 
E

ElmerF

#7
Hi Devicenewbie,

When you say administrative reasons are you referring to the eCopy program? If so the response letter you received would detail precisely why the submission was refused. My first attempt at this did not work due to file naming convention and I simply made the corrections they suggested and followed the ecopy guidance document carefully and resubmitted. It was accepted and 510K number assigned. There was no need to get a review of the changes prior to re-submitting. The initial user fee is of course still valid. Please find eCopy link below which is now compulsory as of January 1 2013.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM313794.pdf

Additional comment: Once you have your 510K number assigned within a week or two you will be assigned your reviewer and direct contact is much easier from that point onwards. Email is best as they need to keep written records of all communication. They will usually require you to send eCopy version of official responses.

Best regards,

Elmer F
 
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