Regulatory
31st May 2007, 11:20 AM
Hi,
We are new to Manufacturing ECG Monitors.
We are planning to Submit the FDA 510 (k) through Substantial Equivalence by comparing with the other ECG Monitors.
We are now preparing the format according to the Guidance for Industry - Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement).
Is this the better way to submit the approval for the 510 (k)?
else
if we choose to submit the file through Comparison Testing with the Predicate Devices....what all the tests we have to do....should be do the clinical testing also!
Waiting for the reply.....................please help us
Al Rosen
31st May 2007, 10:24 PM
Hi,
We are new to Manufacturing ECG Monitors.
We are planning to Submit the FDA 510 (k) through Substantial Equivalence by comparing with the other ECG Monitors.
We are now preparing the format according to the Guidance for Industry - Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement).
Is this the better way to submit the approval for the 510 (k)?
else
if we choose to submit the file through Comparison Testing with the Predicate Devices....what all the tests we have to do....should be do the clinical testing also!
Waiting for the reply.....................please help usWhatever is required to characterize the device. You would probably need the predicate devices 510(k) for this. I would go with the requirements as described in the guidance document.
Regulatory
4th June 2007, 02:54 AM
Should we need the Predicate Devices for the CE Marking procedures also!
Al Rosen
4th June 2007, 09:31 AM
Should we need the Predicate Devices for the CE Marking procedures also!CE marking is a completely different process and does not use a comparison to a predicate device.
Regulatory
4th June 2007, 11:08 AM
Can you please tell the process for submitting the CE mark.......?
Al Rosen
4th June 2007, 11:26 AM
Can you please tell the process for submitting the CE mark.......?Find a notified body. Your ISO 13485 registrar will usually have an association with one.They can help you with the process.
Regulatory
5th June 2007, 03:20 AM
Out Notified Body is very slow in response......so I am here to ask help!
If you know any one...please let me know...so that we can contact them.
Al Rosen
5th June 2007, 09:39 AM
Out Notified Body is very slow in response......so I am here to ask help!
If you know any one...please let me know...so that we can contact them.Pick one from this list of Notified Bodies (http://www.igz.nl/dossierscontentbronnen/49978/Notified_Bodies_medische_hu1.pdf).
Regulatory
5th June 2007, 11:53 AM
Thanks very much...for the document!
I will share my success with you.........Once again..Thanks.
