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Blood Glucose Monitor & its Logbook Website - Do I need to get 510k for the Website?

I

iko422

#1
Hi this is my first time posting thread on this website.

I found so many useful informations regarding FDA regulations from this website and I really appreciate all you guys inputs.

I am a regulatory specialist who works at Blood Glucose Monitoring System manufacturer.

We have devloped a website that the user can record their blood glucose test result and manage it.

The users can plug in their meters and the website can download their data from the meters. (Basically it is online version of logbook)

My question is Do I need to get 510k for this webisite?

I know that I need to get 510k for medical device related softwares.

If I do need to get 510k, what documentations do I need submit along the 510k? (since it is not for the device, I assume that no device description is needed)

Thank you guys in advance and I am looking forward some helps from you guys.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Blood Glucose Monitor & its Logbook Website - Do I need to get 510k for the Websi

Hi this is my first time posting thread on this website.

I found so many useful informations regarding FDA regulations from this website and I really appreciate all you guys inputs.

I am a regulatory specialist who works at Blood Glucose Monitoring System manufacturer.

We have devloped a website that the user can record their blood glucose test result and manage it.

The users can plug in their meters and the website can download their data from the meters. (Basically it is online version of logbook)

My question is Do I need to get 510k for this webisite?

I know that I need to get 510k for medical device related softwares.

If I do need to get 510k, what documentations do I need submit along the 510k? (since it is not for the device, I assume that no device description is needed)

Thank you guys in advance and I am looking forward some helps from you guys.
Hello and welcome to the cove :bigwave:

Step #1: Establish a formal, written, controlled and binding intended purpose statement for this tool (you can informally call it "a device", "a software", "a website" - whatever). That would establish whether or not it's a medical device, and what sort of. Regulatory requirements (if any) would flow from this statement.

The contents of any 510k submission (if required) would come from the FDA's guidance - either the general one or product-code specific. But that's for later. Start from step #1.

Good luck,
Ronen.
 
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