FDA Submission Question

Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#1
#1
Assuming a company has an approved wearable device that presents its measurements to a consumer phone or web interface via 510(k). If a third party had an FDA cleared device and wanted to present their output via our GUI (As is with no adjustments), would an FDA submission be required?
 
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shimonv

shimonv

Trusted Information Resource
#2
#2
I believe so, because you are now presenting information that you didn’t show before, and perhaps your intended use is extended. Furthermore, there is a potential usability issue because the user now sees additional information from the second device, which might affect his overall interpretation of the results from your device. And you are dependent on the results coming in from the other device, which are subject to changes.

-Shimin
 
mihzago

mihzago

Trusted Information Resource
#3
#3
I think you've got a similar answer in another forum, but it depends on what do you intend this information to present and how you present it. If it just displays the data from the device without any modification or analysis then it could fall under MDDS.
 
Orca1

Orca1

Involved In Discussions
#4
#4
Ed Panek said:
Assuming a company has an approved wearable device that presents its measurements to a consumer phone or web interface via 510(k). If a third party had an FDA cleared device and wanted to present their output via our GUI (As is with no adjustments), would an FDA submission be required?
Click to expand...
If a third party with an FDA-cleared device wants to present their output via your GUI without any adjustments, an FDA submission may be required. This is because integrating a new device into your existing system could be considered a significant change or modification that could affect the safety or effectiveness of the device or its intended use (21 CFR 807.81(a)(3)(i) and (ii)).

In such cases, you may need to submit a new 510(k) or a supplement to support the new use or integration (21 CFR 99.3(k)(3)). The submission should include appropriate supporting data to show that the manufacturer has considered the consequences and effects the change or modification or new use might have on the safety and effectiveness of the device (21 CFR 807.87(g)).
 
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