Over the next three months, the clinical and research laboratory community and medical-device manufacturers will be watching what comes of pressure to relieve the burdens and bottlenecks of U.S. and European in vitro diagnostic (IVD) product and medical device regulation.
First, 2024 year-end closing statements in a lawsuit challenging the U.S. Food and Drug Administration (FDA)'s authority to regulate laboratory developed tests (LDTs) concluded with a recommendation to grant the FDA's motion for summary judgment and deny the cross-motions of the plaintiffs, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP).
Filed December 23 in a Texas U.S. District Court, the brief suggests that the court should not order universal vacatur, according to the court filing posted by the AMP. In addition, the document noted that appropriate remedies are not known in the event the court grants any part of plaintiffs’ summary judgment motions. However, Fifth Circuit precedent gives the district court flexibility and considerable discretion to fashion an appropriate remedy, attorneys pointed out.
Among the points made, "the [federal Food, Drug and Cosmetics Act] FDCA empowers FDA to ensure that tests designed and offered by laboratories are capable of generating clinically valid results on which all indicated patients may safely and effectively rely," U.S. Department of Justice (DOJ) attorneys wrote.
Further, attorneys said that if a test is not clinically valid as designed, no amount of laboratory expertise in performing it according to its designed specifications could resolve that defect and produce a clinically valid result. The Clinical Laboratory Improvement Amendments (CLIA) regulation only focuses on laboratory proficiency and regulates test validity in only a narrow analytical sense, they noted.
Industry insiders believe the court's decision on FDA LDT regulation set for Phase 1 enforcement starting May 6 could come in the first quarter of 2025.
Meanwhile, in the European Union (EU), where medical device and in vitro diagnostics regulation changed considerably starting in 2017, the European Parliament placed a March 25 deadline on a targeted evaluation of the EU's Medical Device Regulation (MDR) that became applicable in 2021 and In Vitro Diagnostic Regulation (IVDR) that became applicable in 2022.
There is a push in the EU for swift revisions to ease regulatory bottlenecks but to first help the European Commission (EC) take stock and assess whether the rules are effective, efficient, and proportionate; meet current and emerging needs; relevant; and have added value in the EU.
The EU's MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices, as a response to several high-profile scandals with unsafe medical equipment, with the purpose of ensuring higher standards of safety, transparency, and clinical performance while also fostering innovation in the sector.
LabPulse.com previously reported that laboratories and medical device manufacturers have faced technical and workload challenges with the rollout of the EU's more stringent regulations. In-house assays were brought under the scope of the IVDR, with companies having to justify their use and satisfy new safety and performance requirements.
Like the phased-in plan of the FDA, the EU's MDR and IVDR framework also initiated a series of deadlines for compliance. Since the rollout, however, the government has had to extend deadlines multiple times due to reported difficulties in navigating complex regulatory procedures, according to an October 2024 joint resolution on the urgent need to revise medical device regulation.
By March 25, the IVD and medical device manufacturing community may see a proposed systematic revision of all relevant articles of MDR and IVDR regulations, accompanied by an impact assessment.
The EC may also use legislative and nonlegislative tools to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly small and medium-sized entities, according to the resolution.
Four goals were raised in the resolution:
- Eliminating unnecessary recertification of products and emphasized that certain product updates or adjustments should not necessarily lead to an entire recertification of the product.
- Harmonizing provisions and ensuring consistency across the EU.
- Classifying products correctly and consistently.
- Creating fast-track and prioritization pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies.
Parliament also called on the EC to continuously monitor the availability of devices and to take appropriate action to keep them available in the EU market. In this regard, it called for an urgent full implementation of the European database on medical devices (EUDAMED).
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the EU, according to a program overview. The database will integrate different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers).
"EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU," the EC said, adding that EUDAMED will be composed of six modules related to actor registration, unique device identification (IVD class B and class C devices and class 1 medical devices have a related deadline of May 26) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.
