Impact of the Fda's Ldt Rule on Diagnostic Testing

FDA released their final rule on regulating LDTs yesterday. Unchanged from the proposed rule, FDA will regulate LDTs as medical devices with a four-year implementation period for doing so. The implementation milestones are almost entirely the same. However, there are major changes involving several significant areas of continued enforcement discretion. ❓ Grandfathering Existing Tests FDA will exercise enforcement discretion for (i.e. grandfather) all LDTs on the market prior to the issuance of the final rule (~May 6th, 2024), including premarket review and quality system requirements (QSRs). Laboratories will still need to meet the stage 1 and stage 2 requirements, and will be limited in the modifications that can be made to the LDTs. Note this includes labeling requirements, which means laboratories will need to submit performance information and a summary of supporting validation, as applicable. ❓ New York State-Reviewed Tests FDA will exercise enforcement discretion for LDTs reviewed and approved by NYS. This includes tests that are conditionally approved and those implemented under a category exemption. Laboratories will still need to meet the stage 1 – 3 requirements. ❓ Laboratories Integrated into a Healthcare System FDA will exercise enforcement discretion for LDTs that are performed by a laboratory integrated into a healthcare system, address an unmet need, and are performed on patients receiving care within that same healthcare system. - “Unmet need”: there are no FDA-authorized tests available that meet the patient’s needs (disease or condition, test unavailable to the patient). If an FDA-authorized test becomes available that could address the unmet need, the test no longer qualifies for enforcement discretion. The laboratory would need to cease offering the test or submit the test for FDA review (or leverage another applicable pathway). Note: cost improvement or efficiency gains are not considered sufficient rationales for “unmet need”. - “Same healthcare system”: the test must be ordered by staff with credentials and privileges at a facility owned and operated by the same healthcare system employing the Laboratory Director and performing the LDT. This does not include specimens received from an affiliated hospital that is a different corporate entity. - Laboratories will still need to meet the stage 1 and stage 2 requirements. ❓ Several others Pre-1976 tests, HLA testing, forensic testing, and public health testing I’ll stress this again: continued enforcement discretion does NOT mean a laboratory needs to do nothing. All labs offering LDTs will need to register as medical device manufacturers and list their LDTs in a public database, submit adverse events to FDA, and provide performance characteristics to the FDA (i.e. “labelling”). Labs operating under a NYS enforcement discretion will also need to comply with select QSRs.

🚨 Exciting Update from the FDA on Laboratory Developed Tests (LDTs) 🚨 Today, the FDA announced a significant milestone in healthcare regulation, finalizing a rule that explicitly designates IVDs, including those manufactured by laboratories, as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This update marks a pivotal shift in oversight and quality assurance within the diagnostics industry. Key Highlights: 1. Policy Phaseout for Laboratory Developed Tests (LDTs): Over the next four years, the FDA will implement a phased approach to phase out its general enforcement discretion for LDTs. This includes targeted enforcement discretion policies for specific categories of IVDs produced by laboratories. The phaseout policy contains the following five stages: Stage 1 (Starting May 6, 2025): Compliance expected with medical device reporting, correction and removal reporting, and quality system requirements. Stage 2 (Starting May 6, 2026): Compliance expected with additional requirements such as registration, listing, labeling, and investigational use. Stage 3 (Starting May 6, 2027): Compliance expected with quality system requirements. Stage 4 (Starting November 6, 2027): Compliance expected with premarket review requirements for high-risk IVDs, unless already under FDA review. Stage 5 (Starting May 6, 2028): Compliance expected with premarket review requirements for moderate and low-risk IVDs, unless already under FDA review. The FDA also issued two draft guidance's today: A. Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response: Addresses enforcement discretion for laboratories offering specific unauthorized IVDs during emergent situations like infectious disease outbreaks. B. Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Provides insight into FDA's considerations for enforcement discretion during public health emergencies declared under section 564 of the FD&C Act. This regulatory update reflects the evolving landscape of Laboratory Developed Tests (LDTs) and emphasizes the FDA's commitment to ensuring the safety and effectiveness of diagnostic products. Stay tuned for further developments and guidance as we navigate these changes together! For more info - Check the Link Below #FDA #IVD #HealthcareRegulation #Diagnostics #IVD #LDT

Approx 25 business days until Stage 1 of the US FDA LDT Rule. > This Rule has been in place for 11 months. > The expectation was to start immediately and early and be ready by the Stages not to start them on the implementation date. > Take steps behind the scenes like: 1. Determine “who you are”: Independent? Commercial? Part of a healthcare system incl the VA? High complexity? Are you per FDA definition Manufacturing any products defined as LDTs? Or any other FDA establishment role? 2. Determine what in your Test Menu is defined as an LDT: In-house made? Modified FDA market authorized product? What are those modifications? Do they fall within the Rule? 3. Assign Product Codes to all LDTs per FDA definitions, noting there are dedicated LDT codes in addition to standard IVD 4. Review your current Medical Device Reporting processes and procedures as a User Facility 5. Review Guidance on Complaints, eMDR, Adverse Event Codes, and C&R (note that ISO has a whole complaints series) 6. Set up Publishing software and portal 7. Ensure Complaints - plus other incoming process streams eg CAPAs- are all now tied to Medical Device Reporting 8. Ensure all is in SOP, including process of assessment 9. Create infrastructure for Part 11 Compliant regulatory records 10. Submit test report 11. Initiate readiness for postmarket vigilance of your LDT-IVD products to start Is there anything your lab organization has done that is not mentioned here? Add to comments below!