Comments on the “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and the “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” Draft Guidances
…Since its inception, the Coalition has worked closely with FDA to ensure that any new regulatory framework proposed by FDA for LDTs is reasonable, not overly burdensome, and acknowledges the differences between laboratory services and kits that are distributed to laboratories for performance. We appreciate the time and attention the agency has given to considering the Coalition’s views over the years, and in particular since releasing these latest draft guidances. The Coalition seeks to continue our efforts to work with the FDA toward the development of an appropriate regulatory model for advanced diagnostic tests that both protects public health and promotes innovation. It is critical that the Agency remains open to stakeholder views and adopts well-reasoned changes to the draft guidance that are both clear and not overly burdensome for laboratories.