Navigating the 510(k), IDE and PMA Submission and Approval Processn is a webinar that covers topics such as:
- The 510(k) -- Pre-market `notification` and FDA Device Clearance
- Tougher Expectations / Requirements
- Intended Use / Indications for Use
- Predicates and Substantial Equivalence
- Clinicals -- the `basics`
- The IDE -- Investigational Device Exemption; IRB`s; Disclosures
- Resolving a "Wrong" Decision
- The PMA -- Pre-market Approval
Navigating the 510(k), IDE and PMA Submission and Approval Processn brings together:
- QA
- Senior management in Devices and Combo Products
- R&D
- RA
- Production
- Engineering
- Consultants
- Operations
