How to withdraw a cleared (but never sold in the US) 510(k) Medical Device?

W

wangyang

Hi all:

We have product which will not and have never been to U.S.A market, since the FDA inspector will select device to review from 510(k) database when conducting field inspection, so we don't want to the never marketed device to be inspected by FDA, can we withdraw the cleared 510(k)?Do you know is there any procedure?

Thank you.
 
D

Dudes

The first step should probably be to remove it from your company device listing.

Apart from that, I don't know if there are any other steps necessary. Maybe someone else with better knowledge can chime in....
 
M

MIREGMGR

I agree. US FDA is highly unlikely to review a device that isn't currently Listed and, because it hasn't been marketed in USA, hasn't resulted in any US adverse event reports.
 

v9991

Trusted Information Resource
here's what FDA talks about Withdrawal...

"(h)Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&showFR=1

(d) A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the appropriate Food and Drug Administration district office when the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the Food and Drug Administration will assist the firm in determining the exact nature of the problem.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7&showFR=1

above two references are traceable from following link...
http://www.fda.gov/MedicalDevices/D...nts/RecallsCorrectionsAndRemovals/default.htm
 
M

MIREGMGR

I'm sure the OP's use of the word "withdraw" had nothing to do with field actions, i.e. corrections or removals.
 

v9991

Trusted Information Resource
I'm sure the OP's use of the word "withdraw" had nothing to do with field actions, i.e. corrections or removals.

1) agreed, :truce:
2) but,its only to try provide the reference:read:... cause FDAs guidances/notes have to cover all scenarios., and i only:bonk: tried to provide such a reference which brings to nearest context of withdrawals expressed by OP...
that is the reason why i tried to indicate the withdrawal definitions etc.,
consult with the appropriate Food and Drug Administration district office when the reason for the removal or correction is not obvious or clearly understood but where it is apparent

actually i had followed through my intial search...
further, here's new reference which comes nearest to the context...
If the manufacturer is not marketing the same device in the United States, they should contact the Program Operations Staff and obtain a new classification product code for “export only”. Once a new classification product code is assigned, please contact the Registration and Listing Staff by email for assistance with listing devices that are being exported to a foreign country.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm285317.htm
 
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D

Dudes

One important information would be the location of the manufacturer. If they are based outside of the USA, the "export only" classification would be irrelevant.
 
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