Christine P. Bump’s Post

Today’s #FDA webinar regarding the final rule for #LDTs provided an overview of the rule and enforcement discretion phaseout policy. FDA responded to previously submitted questions seeking clarification on how the rule, phaseout policy, and exceptions to some or all of the phaseout policy apply to specific tests, changes to tests, and test development. Key clarifications made by FDA were: ·      No test is “grandfathered” under the final rule. ·      The trigger date for BOTH the phaseout policy and whether an LDT is currently marketed is May 6, 2024. The phaseout policy is tied to the “publication date," and tests are currently marketed as of the “date of issuance," both of which are May 6, 2024. ·      LDTs introduced after May 6, 2024, but during the phaseout policy, must comply with the five phases of the phaseout policy. ·      FDA intends to use information submitted under Stage 2 (including registration and listing) to inform its negotiation of user fees and review timelines under the next round of Medical Device User Fee Amendments (MDUFA). The agency designed the phaseout policy to have additional resources before Stage 4 (PMA submissions). Answers to specific questions revealed that the following types of tests ARE subject to the phaseout policy (i.e., must comply with Stages 1-5) unless they meet other criteria to continue to fall under full or partial enforcement discretion: ·      “Screening tests” (which are distinct from “public health surveillance” tests that fall outside the scope of the phaseout policy) ·      Therapeutic Drug Monitoring tests that are used beyond “law enforcement” purposes ·      Tests developed at state or local public health laboratories FDA also clarified that there is no general exception or exclusion for tests for rare diseases or unmet needs, and discussed the types of modifications that would subject “currently marketed” LDTs to premarket notification requirements. The agency emphasized that tests approved, conditionally approved, or within an approved exemption from full technical documentation under NY CLEP must comply with all of Stages 1, 2, and 3 of the phaseout policy. FDA will be hosting additional webinars and releasing guidance documents to clarify specific issues under the final rule, including requirements for labeling and considerations for emergency use tests. The next webinar will be on June 5, 2024, and will address “Draft Guidances on Immediate Response Tests and Consideration of Enforcement Policies for Tests in the Context of a 564 Declaration.” The most important clarifications made by FDA are that no LDTs are “grandfathered,” and that “currently marketed” LDTs are those that were on the market by May 6, 2024, as discussed in my May 7, 2024 article. FDA has also prepared a table that lays out what types of tests are subject to which stages of the phaseout policy. FDA’s slides from today’s webinar are available at the link below. The transcript will be posted there soon.

#FDA's final rule regulating #LDTs as medical devices was published in the Federal Register yesterday. While changes to the final rule lessen the burdens many #laboratories were anticipating, #labs still need to invest significant time, money, and other resources to understand and comply. I was attending the Executive War College when FDA released the unpublished version, and had the opportunity to discuss with laboratory and #diagnostics professionals their questions and points of confusion, many of which are addressed in this article. #IVDs #devices #EWC24

Hot off the press! #FDA’s final rule to regulate #LDTs as medical devices is available on the Federal Register’s Public Inspection List, for publication on May 6, 2024!  At first glance, it appears that stakeholder comments led to important changes from the proposed rule that will lessen the anticipated burden on many laboratories when the final rule is implemented. Specifically, under the final rule, FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements (i.e., 510(k), De Novo, and PMA submissions) and quality system requirements (except for records) for: - Currently marketed IVDs offered as LDTs - LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system - Certain non-molecular antisera LDTs for rare RBC antigens FDA also intends to “exercise enforcement discretion and generally not enforce all or some applicable requirements” for: - LDTs that are approved by NYS CLEP - HLA tests - Tests intended solely for forensic (law enforcement) purposes - LDTs manufactured and performed within DoD or VHA For all other LDTs, including those not currently marketed, the five-stage, four-year phaseout of FDA’s enforcement discretion is the same as in the proposed rule with one exception – complying with requirements for complaint files is specifically included in Stage 1. My detailed analysis will be forthcoming. (The final rule is 528 pages, so it is a lot to sort through!) Stay tuned! #diagnostics #devices #labs #IVDs

Thank you, Shadowbox, Inc., for the opportunity to collaborate! Based on the content of yesterday's House Subcommittee meeting and the call from Senator Bill Cassidy, M.D. for information about #LDTs and #FDA's authority, #laboratories must continue engaging! #labs #diagnostics #IVDs

The key takeaway from today’s House Subcommittee on Health hearing, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule,” is that the #VALID Act is a better path forward for providing regulatory certainty for all stakeholders and balancing #LDT accuracy with innovation and access to patients, especially for pediatric patients, rare diseases, small patient populations, and rural populations.   - All five witnesses supported the VALID Act (though Susan Van Meter, President, American Clinical Laboratory Association (ACLA) and Dara L. Aisner, MD, PhD, Medical Director, Colorado Molecular Correlates Laboratory, Professor of Pathology, University of Colorado, Representative of the Academic Coalition for Effective Laboratory Developed Tests, explained that issues and concerns still need to be addressed).   - All five witnesses stated that their organizations would continue to work with Congress to develop an appropriate regulatory framework for all diagnostic tests.   - None of the witnesses agree that the existing medical device framework is the most appropriate or suitable means through which to assure the quality and accuracy of tests.  Discussion revealed that the medical device framework is not ideal for #IVDs generally.   The hearing provided an interesting and insightful discussion with different views about the need for #FDA's review of tests to ensure accuracy and whether there is actually a “major problem that needs a solution.” Many Subcommittee members cited FDA’s proposed rule as an overreach of the agency’s authority and questioned FDA’s capacity to enforce the rule as proposed. Important discussions included the constraints on test innovation, development, and modification under the medical device framework, and the burdensome costs that will lead to a loss of access to tests and consolidation of the laboratory industry. Overall, the VALID Act was repeatedly discussed as a better alternative for all sides.  

Two pieces of good news for #laboratories regarding #LDTs! Thank you, Shannon Bennett for sharing these updates. Will these actions delay FDA’s publication of the final rule to regulate LDTs under the existing medical device framework? First, Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, recognizes that FDA’s proposed rule to regulate LDTs as medical devices is detrimental to innovation and patient care, and exceeds FDA’s statutory authority. Senator Cassidy is seeking feedback from stakeholders on how to modernize current regulations in a way that supports both innovation and patient safety. Stakeholders can submit responses to Senator Cassidy’s questions by email to diagnostics@help.senate.gov by April 3, 2024. (See https://bit.ly/4ahbFSr). Additionally, Rep. Cathy McMorris Rodgers (R-WA), House Energy and Commerce Committee Chair, and Rep. Brett Guthrie (R-KY), Chair of the Subcommittee on Health, announced a hearing to be held on March 21, 2024, titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule.” They also recognize that FDA’s proposed rule “relies on dubious and misguided legal, economic, and public health arguments,” “extends far beyond the scope of any legislative proposals,” and would “threaten access to tests.” (See https://bit.ly/3Vl3ikK). The hearing will be at 10:00 am in the Rayburn House Office Building, and will also be livestreamed online at https://lnkd.in/gt5yUpVV #FDA needs to publish the final rule by April to request resources under the next cycle of user fee legislation. However, lawsuits to stop the implementation and enforcement of the final rule are forthcoming. These actions by Congress may be steps toward serious re-consideration of the #VALID Act. VALID was not ideal, but the #IVCT framework and grandfather clauses present fewer burdens to laboratories than FDA’s planned regulation.   #labs #diagnostics #devices #IVDs

It was an honor to speak about #FDA's proposed #LDT rule at the Q1 Productions Semi-Annual Diagnostic Coverage & Reimbursement Conference in San Diego last week! We discussed several significant developments, including: - The expectation of FDA’s final rule in April 2024 - The impact of FDA device regulation on laboratories - The costs of compliance - FDA’s enforcement ability - The impact of two recent developments: the planned down-classification of many Class III #IVDs and the implementation of the #QMSR Thank you to Q1 Productions and conference sponsors TELCOR Inc, XiFin, Inc., e5 Workflow, Quadax, Inc., FrontRunnerHC, careviso , Policy Reporter, Hull Associates LLC, and Shadowbox, Inc. for an engaging, informative, and valuable event!   #ivd #ldts #diagnostics #labs #laboratories #reimbursement #compliance

A sincere thank you to the team at GenomeWeb for this painstaking analysis of every comment, the sum of which is incredibly helpful to all of us in the industry.