G
Hi All,
I am new to this forum and new to medical devices and I have some questions. I am trying to put together a 510(k) submission for a simple OTC medical device. It is a Micro-current Electro-stimulator combined with an infrared LED panel (product codes NUH and ILY)
In the Acceptance Checklist published by the FDA ( I would post a link but I am not allowed to)
Link - http://www.fda.gov/downloads/Medica...dance/GuidanceDocuments/UCM315014.pdf#page=17
it states in section 10a:
10. a.
If there are requirements regarding the device description, such as
special controls, in a device-specific regulation that are applicable
to the device, the submission includes device description
information to establish that the submitter has followed the
device-specific requirement.
Can someone help me figure out whether my device(s) require this type of description, or more generally, what does this paragraph mean, anyway.
It goes on from there, but let's start with this.
Thank you in advance
Gerhard
I am new to this forum and new to medical devices and I have some questions. I am trying to put together a 510(k) submission for a simple OTC medical device. It is a Micro-current Electro-stimulator combined with an infrared LED panel (product codes NUH and ILY)
In the Acceptance Checklist published by the FDA ( I would post a link but I am not allowed to)
Link - http://www.fda.gov/downloads/Medica...dance/GuidanceDocuments/UCM315014.pdf#page=17
it states in section 10a:
10. a.
If there are requirements regarding the device description, such as
special controls, in a device-specific regulation that are applicable
to the device, the submission includes device description
information to establish that the submitter has followed the
device-specific requirement.
Can someone help me figure out whether my device(s) require this type of description, or more generally, what does this paragraph mean, anyway.
It goes on from there, but let's start with this.
Thank you in advance
Gerhard
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