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- FDA Releases LDT Compliance Guide for Laboratory Manufacturers
Following the Food and Drug Administration (FDA) laboratory-developed test (LDT) final regulation, the agency released: Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff on June 25. This document is intended to be a guide to help laboratories that offer LDTs navigate the new regulatory requirements, and includes background information and guidance on:
- General Scope of Amendment and Phaseout Policy
- Enforcement Discretion Policies for Certain IVDs
- Amendment and Phaseout Policy
- Summary of FDA Compliance Expectations
- Requirements related to Complaints, Medical Device Reports, and Correction and Removal Reports
- Registration and Listing Requirements
- Device Labeling Requirements
- Investigational Use Requirements
- Quality System Requirements
- Premarket Review Requirements
- General Information
In addition to the above resources, the FDA’s webpages for Laboratory Developed Tests and IVD Regulatory Assistance provide more resources about how FDA regulates devices. CDRH (Center for Devices and Radiological Health) also offers additional resources for industry:
- CDRH Learn, a multi-media educational resource, featuring learning modules that address medical device laws, regulations, guidances, and policies, across the entire product life cycle; and
- Division of Industry and Consumer Education (DICE), which answers questions by phone and email from the medical device industry and hosts Device Advice:
- Comprehensive Regulatory Assistance, a web page for CDRH’s comprehensive regulatory education.
For questions about this document, contact LDTFinalRule@fda.hhs.gov. Learn more about what the CAP is doing around Laboratory-Developed Test Oversight.