FDA Approval for LDTs Made Easy
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- 1:032) Get pre-market clearance or approval- 1:04- 1:373) Quality control and quality assurance- 1:38- 2:044) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:215) Ensuring data security and patient privacy- 2:22-...