Thursday, May 20th 2PM ET with Jahan Azizi
- Define a Medical Device per Food and Drug Administration (FDA).
- Describe Federal Code of Registration (CFR), 21 CFR and FDA.
- Discuss how to Determine if Your Product is a Medical Device and the different classes are per the FDA for devices.
- Discuss FDA review process for the Class I, II, and III medical devices and requirements.
- Describe Medical Device Reporting (MDR), Safe Medical Devices Act (SMDA), MedSun and the MAUDE database.