Successfully Navigate the New FDA Regulations for LDTs
The highly anticipated FDA final rule on Laboratory Developed Test (LDT) regulation marks the end of their long-standing enforcement discretion for these products. Although the Agency has made clear on many occasions over the past several decades that LDTs are medical devices regulated under the Federal Food Drug and Cosmetic Act, and laboratories which develop tests are acting as medical device manufacturers, FDA is expected to formally revise the definition of In Vitro Diagnostic Products to explicitly state that IVDs are medical devices, including when the manufacturer of the IVD is a laboratory.
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This significant paradigm shift will upend laboratory operations all over the globe. Many laboratories will need to perform rigorous verification and validation for their test(s), evolve their CLIA quality system to include FDA-specific requirements, and submit pre-market submissions to FDA for their test(s) to remain commercially available. With some regulations (e.g. MDR, Correction and Removal reporting) becoming effective as soon as one year from final rule publishing, laboratories do not have long to adapt. OnemataDC knows this road is foreign to many, and embarking on such a journey with an experienced, reliable guide to help navigate these regulations can reduce risk and limit or prevent business disruption.
Contact us for expert LDT regulatory and quality assistance
The OnemataDC LDT Consultant Team
Our team of LDT consultants is comprised of regulatory and quality professionals with deep backgrounds in laboratory operations and IVD regulation, including the current FDA rules and enforcement specific to LDTs. We collaborate with each laboratory to right-size the augmentation to their CLIA quality system to ensure compliance with FDA regulations while not over-burdening the organization or laboratory processes. Our LDT experts are also proficient in IVD standards and regulations to assist in verification and validation appropriate for each type of test. The regulatory team is unmatched in devising creative and compliant regulatory strategies, authoring regulatory submissions, and liaising with FDA to facilitate successful and timely submission clearance or approval. The OnemataDC LDT consultant team provides both strategic and hands-on guidance to successfully, promptly, and cost-effectively, navigate this new normal in LDT enforcement.
Client Success and Satisfaction
OnemataDC is committed to helping patients and advancing life science innovation, and we can’t be successful unless our clients are successful. We’re proud to have a 100% success rate in our FDA submission clearances and approvals. Laboratories can rely on us to advise them through complex compliance hurdles, as well as be there each step of the way. We tailor our solutions to each organization and each project, providing what you need when you need it. Our collaboration, communication, and expertise make us the go-to partner for laboratories to navigate the new LDT regulatory landscape with confidence.
What You Need to Know About the Proposed Rule
FDA has proposed a rule which would modify the LDT regulatory framework which has been in place for decades. Within this framework, LDTs would formally be included within the definition of IVDs and be subject to all applicable medical device and IVD regulations, including but not limited to, medical device report (MDR), correction and removal reporting, establishment registration and device listing, quality management system requirements, and, depending on risk, premarket review.
The Agency’s effort to have more oversight of LDTs stems generally from the fact that LDTs in 1976 (when the LDT enforcement discretion policy began) vary greatly from the LDTs of today, and from concerns of test validity, which has a significant impact on public health. Today’s LDTs are more often used to inform or direct critical treatment decisions, to widely screen for common diseases, to predict personal risk of developing certain diseases, and to diagnose serious medical conditions such as cancer and heart disease. Many tests developed and used by laboratories are functionally the same as those made by other manufacturers of IVDs, yet neither the LDT nor laboratory had any FDA oversight. As such, FDA believes the enforcement discretion policy for LDTs is no longer in the best interest of public health, and to best promote and protect public health, this new LDT framework will ensure that these tests meet safety and efficacy standards.
Manufacturers of LDTs should be informed of and start preparing for these imminent changes, which will significantly disrupt how LDTs are developed, validated and commercialized within the healthcare industry.
Below are the key highlights of the proposed rule:
Defined as IVD
The proposed rule will officially modify the definition of an IVD to state that IVDs are medical devices, even when developed by a laboratory
Broad Scope
The scope of the phaseout policy applies to IVDs that are manufactured and offered as LDTs
Phaseout Approach
The enforcement discretion of LDTs will be phased out in 5 phases over 4 years from the date of final rule publication
Longer Phaseout for Small Labs
FDA may be allowing small laboratories (e.g. less than $150,000 in annual revenue) to have a longer phaseout
Limited Exclusions
Very few tests will be excluded from the phaseout policy, including “1976-type” LDTs, HLA tests, forensic tests and public health surveillance tests
Grandfathering
LDTs currently commercially available would not be “grandfathered” and would be subject to the phaseout policy, but FDA asked for feedback on such an approach
How OnemataDC Can Lead You to FDA Compliance
As FDA implements the LDT enforcement discretion phaseout policy and new regulations become effective for LDT manufacturers, OnemataDC can help ensure your market presence is not put into jeopardy. FDA and CMS/CLIA regulatory frameworks are different in scope, focus and purpose, but are intended to be complementary. It’s crucial you partner with a firm that understands and values your effort to maintain CLIA certification, and can seamlessly incorporate FDA requirements into your current operations while also being mindful of your deadlines and budget.
Our team has extensive laboratory experience, and understands the unique challenges that FDA requirements present to laboratory operations. We can help you ensure the right resources are being utilized efficiently and appropriately to optimize not only your compliance, but your processes as well. With the right partner, you can achieve compliance while not putting your patients, customers or market presence at risk.
OnemataDC can support your LDT compliance through several approaches, which include but are not limited to:
Regulatory Strategy and Execution
Many tests will need FDA review and authorization prior to remaining on the market or entering the market. Based on our decades of IVD regulatory experience, we can develop a creative and compliant regulatory strategy for your test(s) and execute upon the strategy to ensure your test commercialization plan is not disrupted.
Premarket Submissions
Our regulatory team with expert knowledge in IVDs can author any necessary premarket submission (Q-Sub, 510(k), De Novo, HDE, PMA) for your test(s). We have decades of experience in FDA submissions, including submissions for IVDs specifically. The regulatory consulting team is comprised of professionals of all levels, ensuring cost-effective and timely service.
Agency Communication
We have worked hard to establish report with Agency and understand what it takes to have effective communication with the FDA review team. It’s also likely that a pre-submission/Q-submission will be helpful for facilitating a smooth review for an eventual premarket submission. We can lead you through this process by preparing the team for an FDA meeting or acting as the correspondent with the Agency during submission review, to facilitate the most successful outcome.
Training
To maintain compliance, staff must understand and adapt to FDA requirements. We can train all levels of staff to the FDA requirements pertinent to their role, setting the groundwork for long-term compliance.
QMS Strategy and Deployment
OnemataDC knows that compliance with CLIA requirements provides some quality assurances that may be relevant to laboratory manufacturing practices. With this knowledge we can design a QMS strategy that does not disregard your existing quality system and that will enhance your current QMS to incorporate FDA-specific requirements. Our multi-level resources can deploy the strategy in a timely and cost-effective manner.
Verification and Validation
LDTs will have to meet standards for safety and efficacy, and be able to demonstrate those standards are met. Our team can help you design, write and execute verification and validation activities to provide you, your customers and patients the assurance that your test performs as intended.
Internal and External Audit
With the requirement for laboratory establishments to register with FDA, comes the inevitable FDA inspection. It’s paramount that your staff and quality system are prepared. Our team, which includes veteran FDA investigators, can perform internal audits, mock FDA audits, and can provide front room and/or back room support during an FDA inspection. We can also provide strategic and hands-on assistance for any remediation activities that are identified through the course of an audit.
Product Lifecycle Support
LDTs will be subject to post-market requirements, such as compliant handling, MDR, correction and removal reporting, establishment registration and device listing, and more. We can provide your desired level of support at any phase of the product lifecycle to ensure your compliance now and in the future.
Gap Analysis and Remediation
CMS/CLIA requirements are different, but complementary, to FDA requirements. Our team, proficient in both CLIA and FDA requirements, can help you identify any gaps in your current quality system, processes, operations, or design documentation, and can provide both strategic and hands-on remediation support.
Learn more about our services and capabilities and how we can support you through your compliance journey