FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the warning letter issued to Rodo Medical who was warned for the following:
- Failing to obtain an Investigational Device Exemption (IDE) for the study. FDA does not accept that the study had been initiated under "good faith" that the device could follow the 510(k) route.
- Failure to monitor the study adequately, specifically the investigator did not provide evidence that an IRB had approved the protocol or informed consent
- Failure to maintain adequate records, specifically adverse events