Summary of the issue:
FDA announced new actions to strengthen the safety and effectiveness of Laboratory Developed Tests (LDTs) through stricter regulations and targeted enforcement.
- Increased FDA Oversight: The FDA is actively working to ensure the safety and effectiveness of Laboratory Developed Tests (LDTs) through targeted enforcement and new regulations.
- Focus on Patient Safety: The primary goal of the FDA’s actions is to protect patients and healthcare professionals by ensuring LDTs are accurate and reliable.
- Continued Access to Critical Tests: While implementing stricter regulations, the FDA aims to maintain patient access to crucial LDTs needed for various health care decisions.
“LDTs” are now termed “IVDs offered as LDTs” and they will be regulated as medical devices by FDA within the framework of 21 CFR 820 Quality System Regulation
The Final Rule:
Federal Register :: Medical Devices; Laboratory Developed Tests
Timeline:
Laboratory Developed Tests | FDA
The phaseout policy contains the following five stages:
- Stage 1: beginning on May 6, 2025, which is 1 year after the publication date of the final LDT rule, FDA will expect compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.
- Stage 2: beginning on May 6, 2026, which is 2 years after the publication date of the final LDT rule, FDA will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and investigational use requirements.
- Stage 3: beginning on May 6, 2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1).
- Stage 4: beginning on November 6, 2027, which is 3½ years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
- Stage 5: beginning on May 6, 2028, which is 4 years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
FDA Webinars: (source – CDRH Learn | FDA)
Enforcement Policies for Certain In Vitro Diagnostic Devices – Draft Guidances (Updated 6/11/2024)
Presentation External Link Disclaimer Printable Slides Transcript
In Vitro Diagnostic Product (IVD): Classification (Updated 8/18/2024)
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In Vitro Diagnostic Products (IVDs) – MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (Updated 8/27/2024)
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Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) (Updated 9/27/2024)
Presentation External Link Disclaimer Printable Slides Transcript
Laboratory Developed Tests; Medical Devices: Proposed Rule
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Exclusions:
