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 and patient privacy- 2:22- 2:43
6) Conducting post-market surveillance- 2:44- 3:03
7) Staying proactive in meeting new compliance requirements- 3:04- 3:20
For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959.
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