Off the shelf Serial to USB Adapter Impact on 510k

S

Silvertabb

#1
To me an off the shelf serial to usb adapter is not a medical device.

(1) If a company wants to buy and stock this product for shipment to their customer, from regulatory and quality stand point what needs to be in place?
(2) Is there any impact to the cleared 510k for the device with which this will be used?
(3) If the company wants to stock this, what are the traceability, labeling and packaging requirements that need to be fulfilled?
(4) Are there any legal implications that one needs to be concerned with?
(5) If the product is bought off the shelf with no agreement with the manfacturer, what are the downsides from regulatory and quality stand point?
(6) Does this adapter become a Class II medical device, now that you use it with you Class II medical device?

Assumptions:
1) The adapter is off the shelf product and is CE marked
2) It has it own original packaging
3) The adapter has been tested and proven to work with your class II medical device
 
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G

gathagmador

#2
There is no impact on your 510k what so ever as long as you did not specify in the submission an exact adapter by brand name. You would need to do, which you did mention is validation that this new adapter works as well as documentation such as a file note justifying the use of the new adapter. I would also leave the adapter in the original packaging it was purchased in (which you also mentioned).
 

Ronen E

Problem Solver
Staff member
Moderator
#3
To me an off the shelf serial to usb adapter is not a medical device.

(1) If a company wants to buy and stock this product for shipment to their customer, from regulatory and quality stand point what needs to be in place?
(2) Is there any impact to the cleared 510k for the device with which this will be used?
(3) If the company wants to stock this, what are the traceability, labeling and packaging requirements that need to be fulfilled?
(4) Are there any legal implications that one needs to be concerned with?
(5) If the product is bought off the shelf with no agreement with the manfacturer, what are the downsides from regulatory and quality stand point?
(6) Does this adapter become a Class II medical device, now that you use it with you Class II medical device?

Assumptions:
1) The adapter is off the shelf product and is CE marked
2) It has it own original packaging
3) The adapter has been tested and proven to work with your class II medical device
Hi there,

Your post is a bit confusing to me, because it's hard to tell whether you relate to the USA regulation or the EC one (or else?). Class II per-se exists in the USA but not in the EC (which has either IIa or IIb), while you also referred to CE marks (as well as 510k). Some of the answers depend on the specific system you're addressing. I'll try to comment with relation to the EC system:

1) If you market / distribute the adapter with any written (maybe even just verbal) indications that it is intended for use with a medical device - enabling the latter to perform as intended - then the adapter may very well be considered an accessory to a medical device. In such case the MDD is applicable to the adapter, with all relevant implications. If you merely stock the adapter and further distribute it in its original packaging with its original labelling, without making any claims regarding its intended use (with a medical device), and this adapter is already duly CE-marked, then you may be exempt from applying the MDD requirements to it.

2) Not unless the accessory was part the original submission.

3) Refer to section #1 above.

4) You better seek qualified legal advice (I wouldn't seek it in a QA/RA forum :))

5) You will have no guarantee that the specification of the purchased adapter will not change without you being notified in advance. This is bad when dealing with medical devices (well, it also depends on the criticality of the item at hand, in the overall setting).

6) Depends on classification rules, which are specific to the territory, so it's hard to say before this is clarified.

Cheers,
Ronen.
 
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