Preparing for the LDT Regulation 2015 is a webinar that covers topics such as:
- The new requirements for adverse event report that apply to LDTs
- He need to notify FDA of all LDTs within six months
- The requirements for premarket review, the timing, and some of the fees
- The role of registration and listing and the current fees
- LDTs that FDA won’t regulate
- The structure of FDA’s schedule for premarket review
Preparing for the LDT Regulation 2015 is intended for:
- Laboratory Technical Supervisor
- Laboratory Directors and Managers
- Regulatory Affairs Managers
- Quality Assurance Managers
- Program Managers