fda substantial equivalence – FDA 510(k) Consulting Service for Medical Devices http://www.fda-510k.com FDA 510(k) Consulting Service for Medical Devices Wed, 22 May 2013 09:10:04 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.3 How to Determine Substantial Equivalence for an FDA 510k http://www.fda-510k.com/how-to-determine-substantial-equivalence-for-an-fda-510k/ http://www.fda-510k.com/how-to-determine-substantial-equivalence-for-an-fda-510k/#respond Tue, 23 Apr 2013 10:32:00 +0000 http://www.fda-510k.com/?p=2866 An FDA 510(k) Premarket Notification is a document containing information required under 21 CFR 807 Subpart. It is based on the concept of substantial equivalence (SE) to a medical device legally marketed in the USA (or predicate device). An FDA 510(k) Premarket Notification provides a comparison between the medical device to be marketed and the predicate device or devices.

 What is substantial equivalence (SE)?

A medical device is substantially equivalent if, in comparison to a predicate device, it has the same intended use and it has the same technological characteristics.

Similarly a medical device is substantially equivalent if, in comparison to a predicate device, it has the same intended use but with different technological characteristics, and the information submitted to FDA do not raise new questions about safety and effectiveness and demonstrate that the device is at least as safe and effective as the legally marketed device.

ISOplan USA can help you determine if your medical device is substantially equivalent to another medical device legally marketed in the USA and if an FDA 510(k) submission is appropriate for your case.

For further information about the FDA 510(k) Approval Process please check the following links:

 

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