Preparing for the LDT Regulation 2015

Topics

• 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

Who should Attend

• Laboratory Technical Supervisor
• Laboratory Directors and Managers
• Regulatory Affairs Managers
• Quality Assurance Managers
• Program Managers