Upgrading medical device at healthcare establishments (user facility)

shrutisancheti

Starting to get Involved
#1
Hello.

I have a question regarding "Medical device upgrade at user facility" as per US FDA requirements.

Here, upgrade means addition of one modality (e.g. CT scan) to the already existing modality (e.g. SPECT), i.e. change in safety and effectiveness of the overall device.

If manufacturer already holds a 510(k) approval for SPECT and SPECT/CT models with same configuration, will he be able to modify SPECT at user facility to SPECT/CT?? If yes, please help explaining how.. Also, if any guidance document available by US FDA, will be very helpful.

Waiting for reply.

Thank you in advance.

Best regards,
Shruti
 
Elsmar Forum Sponsor

shrutisancheti

Starting to get Involved
#3
Thank you Al Rosen for your reply..

However, I think my question is different.

"Please note that both of modalities, namely, SPECT and SPECT/CT are 510(k) approved. Initially, OEM sold SPECT to client (which is 510(k) approved), and now based on client's requirements, he wants to upgrade previously sold SPECT to SPECT/CT to the client's facility. Please note that this modality is also 510(k) approved. So how can he do this upgrade being compliant to US FDA norms??
Major concern is: If he does assembly (i.e. integration of SPECT with CT) and integration testing at user facility itself, will it be acceptable by US FDA?? If yes, does he need to follow 21 CFR 820 at user facility too??"

Please help.

Thank you
 

Al Rosen

Leader
Super Moderator
#4
Thank you Al Rosen for your reply..

However, I think my question is different.

"Please note that both of modalities, namely, SPECT and SPECT/CT are 510(k) approved. Initially, OEM sold SPECT to client (which is 510(k) approved), and now based on client's requirements, he wants to upgrade previously sold SPECT to SPECT/CT to the client's facility. Please note that this modality is also 510(k) approved. So how can he do this upgrade being compliant to US FDA norms??
Major concern is: If he does assembly (i.e. integration of SPECT with CT) and integration testing at user facility itself, will it be acceptable by US FDA?? If yes, does he need to follow 21 CFR 820 at user facility too??"

Please help.

Thank you
The user facility would be an assembler. Look at Assembler’s Guide to Diagnostic X-Ray Equipment to start and go to the FDA's web site for more information.
 

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