Based on the question, I am making the assumption that you are starting a study of a drug using an FDA-approved device. FDAMA does not address device studies. However, if the device has a drug imbedded within it (ie, drug-eluding stents) or a drug is being delivered via the device, it may be required to be registered according to FDAMA if the trial has efficacy endpoints and meets the other requirements of FDAMA. Phase 1 trials do not need results reported on ClinicalTrials.gov at this time.