Concerning the FDA and medical devices we have some 510k for class II that we would like to discontinue. The issue is that we have other medical devices that refer to the DHF/510k submissions that we would like to obsolete. It means that they share some instruments or disposables for example. My question : can we still referring to this 510K and/or DHF that have been obsoleted ? or do we need to keep the DHF open and the 510k could be inactivated ? Thanks very much
FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed
- Thread starter REMV
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What do you mean by inactivating the 510k? Are you going to ask the FDA to expunge their record of the 510k? If the DHF is common to other devices I think it would need to be maintained for the devices that you are actively supplying. You may want to identify the items in the DHF related to the discontinued devices as "archived" for historical; purposes and segregate them. You need to maintain your records for the expected life of the device, but no less than 2 years.
You can inactivate a listing here https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list#9
You can inactivate a listing here https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list#9
Hi AI,
Thanks very much for your feedback.
We want only to obsolete some products. We want to inactivate them because we would like to stop mainting their DHF. However, as you have mentioned : we need to keep active these DHF if they are common to other devices.
We wanted to now if we could introduce those common devices in the DHF of the other ones that will remain active.
Thanks very much
Thanks very much for your feedback.
We want only to obsolete some products. We want to inactivate them because we would like to stop mainting their DHF. However, as you have mentioned : we need to keep active these DHF if they are common to other devices.
We wanted to now if we could introduce those common devices in the DHF of the other ones that will remain active.
Thanks very much
primavesvera
Involved In Discussions
I have a similar question.
We have one device that has been 510(k) cleared and now we would want to submit a Special for modifications to the cleared one. When the 2nd one gets clearance, can we sell both devices, previous and the current version? The first one does not become obsolete with new clearance?
Thanks in advance for the help.
We have one device that has been 510(k) cleared and now we would want to submit a Special for modifications to the cleared one. When the 2nd one gets clearance, can we sell both devices, previous and the current version? The first one does not become obsolete with new clearance?
Thanks in advance for the help.
Yes, it can be marketed regardless of the newer device which it is the predicate of.
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