Chat GPT wasn't around in 2022, but the 400-page VALID ACT was, and for a while, VALID had some momentum in Congress.
See a May 2022 article where authors Boiani and Robertson at Epstein Becker Green note that a version of VALID was attached to FDA user fee legislation:
That article links to a still-up 400 page VALID version.
https://www.help.senate.gov/imo/media/doc/FDASLA%20Discussion%20Draft%20May%2017%202022.pdf
CHAT GPT wasn't around in 2022 to read VALID ACT, but it is now. See below.
As a bonus, in closing I asked Chat GPT to also compare the 400 page VALID ACT and the 160 page FDA LDT rule.
Robots work to compare VALID and LDT RULE. Results below.
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Summarize the VALID ACT.
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The VALID Act (Verifying Accurate Leading-edge IVCT Development Act) of 2022, included but not finalized as part of the FDASLA Act, represents a landmark effort to establish comprehensive regulatory oversight for laboratory-developed tests (LDTs).
Traditionally, LDTs have been regulated under the Clinical Laboratory Improvement Amendments (CLIA), which focus on the laboratories performing the tests rather than the tests themselves. Had it passed, this act aimed to bring these tests under the regulatory purview of the Food and Drug Administration (FDA), establishing a risk-based framework for their evaluation and oversight.
Key Provisions of the VALID Act:
Risk-Based Framework: The VALID Act proposes a regulatory structure that categorizes in vitro clinical tests (IVCTs) based on the potential risk they pose to patients. This framework allows the FDA to apply different levels of scrutiny and oversight depending on the risk associated with each test. High-risk tests, which are more likely to impact patient outcomes if inaccurate, will undergo more rigorous review processes, while lower-risk tests may be subject to less stringent requirements. This tiered approach ensures that the regulatory burden is proportional to the potential risk, promoting patient safety without stifling innovation.
Pre-Market Review and Technology Certification: The act introduces the concept of a pre-market review for higher-risk tests, requiring manufacturers to submit data demonstrating the safety and efficacy of their tests before they can be marketed. In addition to this, the VALID Act also proposes a technology certification process. Laboratories that meet certain criteria and demonstrate consistent quality and reliability in their testing processes can receive certification. This certification allows them to develop and modify tests without seeking FDA approval for each individual test, provided they adhere to the certification standards. This approach aims to strike a balance between ensuring test quality and fostering innovation.
Transitional Provisions and Implementation: Recognizing the complexity and scope of these new regulations, the VALID Act includes provisions for a phased implementation. This transition period allows laboratories and manufacturers time to adapt to the new requirements. It includes clear guidelines and timelines for compliance, ensuring that the industry can move towards these new standards in a structured manner. The act also establishes an emergency use authorization (EUA) pathway for IVCTs, similar to the EUA process used during the COVID-19 pandemic. This allows for the rapid deployment of tests in public health emergencies, ensuring timely access to critical diagnostic tools.
FDA Oversight and Enforcement: The VALID Act grants the FDA enhanced authority to oversee the development, marketing, and use of IVCTs. This includes the ability to inspect facilities, review test data, and take enforcement actions against laboratories and manufacturers that fail to comply with the regulatory requirements. The act also emphasizes post-market surveillance, requiring manufacturers to monitor the performance of their tests and report adverse events. This ensures that any issues with test accuracy or reliability are promptly identified and addressed.
Resources and Funding: To support the implementation and enforcement of these new regulations, the VALID Act outlines the need for additional resources. This includes the establishment of user fees, similar to those used in other areas of FDA oversight, to fund the review and regulation of IVCTs. These fees will provide the FDA with the necessary funding to carry out its expanded responsibilities under the act, including conducting pre-market reviews, inspecting facilities, and overseeing post-market surveillance.
Implications for the Industry:
The VALID Act marks a significant shift in the regulation of laboratory-developed tests. By bringing LDTs under FDA oversight and establishing a risk-based framework, the act aims to ensure that all tests used in patient care meet consistent standards of quality and reliability. This has important implications for both patients and the healthcare industry. For patients, it promises more reliable and accurate diagnostic tests, which are crucial for guiding treatment decisions. For laboratories and test developers, it introduces new regulatory requirements and potential challenges, but also offers opportunities for innovation through the technology certification pathway.
In summary, the VALID Act seeks to modernize the regulatory landscape for laboratory-developed tests, providing a structured, risk-based approach to ensure test quality and patient safety while fostering innovation in diagnostic testing. This legislation aims to create a balanced regulatory environment that addresses the needs of patients, healthcare providers, and test developers in an evolving healthcare landscape.
SIDEBAR - KEY POINTS of VALID
Here are 15 key takeaways from the VALID Act of 2022:
Risk-Based Regulation: The act introduces a risk-based framework for the regulation of in vitro clinical tests (IVCTs), including laboratory-developed tests (LDTs), with higher-risk tests requiring more stringent review.
FDA Oversight: For the first time, LDTs will fall under the direct regulatory authority of the FDA, moving beyond the existing CLIA framework, which focuses primarily on laboratory operations.
Pre-Market Review: High-risk tests will need to undergo pre-market review by the FDA, where manufacturers must provide data to demonstrate safety and efficacy before these tests can be marketed.
Technology Certification: The act establishes a technology certification process for laboratories that demonstrate consistent quality and reliability, allowing them to modify tests without FDA approval for each test.
Emergency Use Authorization: The VALID Act includes provisions for emergency use authorizations (EUA) for IVCTs, enabling rapid deployment of diagnostic tests during public health emergencies.
Transitional Implementation: A phased implementation period is included to allow laboratories and manufacturers time to adapt to the new regulatory requirements, ensuring a smoother transition.
Post-Market Surveillance: The act emphasizes the importance of post-market surveillance, requiring manufacturers to monitor the performance of their tests and report any adverse events or inaccuracies.
Enforcement Authority: The FDA gains enhanced authority to inspect facilities, review test data, and take enforcement actions against non-compliant laboratories and manufacturers.
User Fees: To support the expanded regulatory activities, the VALID Act proposes the establishment of user fees, similar to those in other areas of FDA regulation, to fund the review and oversight processes.
Grandfathering of Existing Tests: Tests that are already on the market before the act's implementation may be subject to specific grandfathering provisions, which can exempt them from certain requirements temporarily.
Harmonization with International Standards: The VALID Act seeks to align with international standards and practices in diagnostic testing to facilitate global harmonization and improve the reliability of tests across different markets.
Flexible Pathways for Innovation: The act provides pathways for innovation, particularly through the technology certification process, which allows certified laboratories more flexibility in test development and modification.
Safety and Efficacy Assurance: The primary goal of the act is to ensure that all IVCTs, especially high-risk LDTs, meet rigorous standards for safety, accuracy, and reliability, thereby protecting patient health.
Impact on Laboratories: Laboratories will need to adhere to new regulatory standards and may need to invest in compliance measures, data generation for pre-market review, and post-market surveillance activities.
Public Health Focus: By improving the regulatory oversight of IVCTs, the VALID Act aims to enhance public health outcomes by ensuring that diagnostic tests used in patient care are both accurate and reliable.
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After taking a deep breath, compare the VALID ACT (never passed legisislation) to the FDA LDT REGULATION (finalized in May 2024.)
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Comparison of the VALID Act and the FDA's 2024 LDT Regulation
VALID Act Overview:
- Risk-Based Framework: The VALID Act introduces a risk-based regulatory structure for in vitro clinical tests (IVCTs), including LDTs, with higher-risk tests undergoing more rigorous review. It provides a technology certification pathway, offering flexibility for certified labs to develop and modify tests without FDA approval for each test.
- Pre-Market Review: High-risk tests need to undergo FDA pre-market review, requiring manufacturers to demonstrate safety and efficacy before marketing.
- Transitional Implementation: The Act includes a phased implementation period, allowing laboratories to adapt to the new requirements. It also establishes an emergency use authorization (EUA) pathway for IVCTs.
- FDA Oversight: It grants the FDA authority to oversee the development, marketing, and use of IVCTs, including inspections and post-market surveillance.
- User Fees: The Act proposes establishing user fees to support regulatory activities.
- Grandfathering: Existing tests may be subject to specific grandfathering provisions.
- Technology Certification: Certified labs can develop and modify tests without seeking FDA approval for each modification.
FDA's 2024 LDT Regulation Overview:
- IVDs as Medical Devices: The regulation clarifies that in vitro diagnostic products (IVDs), including those manufactured by laboratories as LDTs, are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- Phasing Out Enforcement Discretion: The FDA is phasing out its general enforcement discretion for LDTs, ensuring they are subject to the same enforcement approach as other IVDs. This includes MDR requirements, registration, listing requirements, labeling requirements, and pre-market review for higher-risk IVDs.
- Four-Year Transition Period: The regulation introduces a four-year phaseout period, with compliance expectations rolling out in stages, starting from July 5, 2024.
- Scope of Regulation: The rule applies to IVDs manufactured by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and used within such laboratories.
- Specific Provisions: There are targeted enforcement discretion policies for certain categories of LDTs, such as those manufactured within the Veterans Health Administration (VHA) or Department of Defense (DoD) and certain New York State CLEP-approved LDTs.
- Premarket Review: By the fourth year, the regulation expects compliance with premarket review requirements for moderate and low-risk IVDs offered as LDTs.
- Enhanced Oversight and Benefits: The regulation aims to address the increased complexity and wider use of LDTs, emphasizing patient safety, effectiveness, and the reduction of misdiagnosis-related harms. The FDA anticipates annualized benefits over 20 years ranging from $0.99 billion to $13.62 billion, offsetting estimated compliance costs.
Key Differences:
- Legislative vs. Regulatory: The VALID Act is proposed legislation that would have required Congressional approval, while the FDA's LDT regulation is a final rule issued by the FDA itself.
- Risk-Based Approach: Both the VALID Act and the FDA’s regulation propose a risk-based framework, but the VALID Act provides a more defined pathway for high and low-risk tests, including a technology certification process.
- Implementation and Transition: The VALID Act suggests a transitional period with an emphasis on technology certification to facilitate adaptation, whereas the FDA's rule implements a four-year phased approach to full compliance.
- FDA's Authority: The FDA's 2024 regulation solidifies the FDA's authority over LDTs as medical devices, ending its longstanding enforcement discretion.
- Specific Enforcement Policies: The FDA's regulation includes detailed enforcement discretion policies for specific groups and conditions, such as LDTs within the VHA or approved by New York State CLEP, which the VALID Act does not explicitly address.
- Emergency Use Pathway: Both frameworks introduce or reference emergency use pathways, but the VALID Act emphasizes this as part of a broader emergency preparedness strategy.
- Scope and Coverage: The FDA's rule applies explicitly to LDTs within CLIA-certified labs, aligning with its existing device regulation structure, while the VALID Act seeks to establish a distinct regulatory category for IVCTs.
In summary, while both the VALID Act and the FDA's 2024 regulation aim to increase oversight and ensure the safety and effectiveness of LDTs, they differ in their approach, implementation strategy, and specific provisions for regulation and compliance.
