The FDA approval requires some proof for the electrical characteristics claimed. Is the ADAS1000-4 FDA approved? If not, are there some test results for parameters such as patient leakage current, CMRR, input impedance, etc?
FDA approval applies to the ECG system - not to the actual ADAS1000 IC itself.
You would need to design your system to adhere to the various requirements (leakage current, CMRR, input impedance, noise etc). The ADAS1000 has been designed such that it can achieve the performance required by the relevant IEC standard, however in the system itself, there will be other components etc - so it's the system level testing that is important to meet these requirements.
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