FDA Approval for LDTs Made Easy

Send us Fan Mail The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process. Key steps include: 1) Develop a risk-based framework- 0:39- 1:03 2) Get pre-market clearance or approval- 1:04- 1:37 3) Quality control and quality assurance- 1:38- 2:04 4) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:21 5) Ensuring data security an...