FDA Approval Process for Medical Devices is a conference that covers topics such as:
- How the four difference 510(k) applications work, including substantial equivalence, biocompatability and reusable or single-use device control
- The FDA including law, definitions and establishment registration
- The Requirements of a Pre-Market Approval (PMA) including clinical studies, non-clinical studies and post-approval requirements
- How to obtain an Investigational Device Exemption (IDE) including investigational plan, signifcant risk vs non-significant risk and FDA actions on applications
FDA Approval Process for Medical Devices brings together regulatory, technical, clinical and quality professionals.
FDA Approval Process for Medical Devices will be held on 12-13 September 2022.