CLN - Regulatory Roundup

FDA Proposes a New, Streamlined 510(k) Pathway

In the draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria,” the Food and Drug Administration (FDA) proposes new options for demonstrating substantial equivalence for 510(k) submissions through the Abbreviated 510(k) program. Currently, manufacturers seeking 510(k) clearance must prove the safety and efficacy of new devices through comparative testing against predicate devices. However, predicate devices can be old and in certain cases might not closely reflect the modern technology embedded in new devices. If finalized, this guidance would establish a voluntary program for certain well-understood device types that would permit companies to demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device. By allowing a set of objective, transparent, and well-validated performance metrics to serve as the benchmark for evaluating some new devices, FDA aims to offer a more efficient and less burdensome regulatory pathway while maintaining standards for safety and effectiveness.

The agency is seeking comments through July 11 on this draft document at

Guidance for Next-Generation Sequencing Tests Finalized by FDA

The Food and Drug Administration (FDA) has finalized two guidance documents designed to enhance collaboration among researchers and drive the efficient development of novel next-generation sequencing (NGS)-based tests. The first guidance, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics,” describes a streamlined regulatory approach that allows test developers to rely on clinical evidence from FDA-recognized public databases to support clinical claims for their tests and provide assurance of the accurate clinical evaluation of genomic test results. The second guidance, “Considerations for Design, Development, and Analytical Validation of NGS-Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases,” provides recommendations for designing, developing, and validating NGS-based tests used to diagnose individuals with suspected genetic diseases. The document also clarifies how FDA evaluates premarket submissions to determine an NGS-based test’s analytical validity, including how well a test detects the presence or absence of a particular genomic change.

First Test for Drug-Resistant Yeast Gets FDA Authorization

Through the de novo premarket review pathway, the Food and Drug Administration (FDA) has authorized the first test to identify the emerging pathogen Candida auris (C. auris), a yeast that is frequently resistant to multiple antifungal drugs. Specifically, FDA has permitted Bruker Daltonik to expand marketing of the Bruker MALDI Biotyper CA system to include the identification of C. auris, adding to the system’s already cleared uses for the identification of 424 clinically relevant bacteria and yeast species. The Bruker MALDI Biotyper CA system uses matrix-assisted laser desorption/ionization mass spectrometry in combination with a reference organism database to identify pathogens. FDA evaluated the use of a standard protocol for adding C. auris to the system database in conjunction with the performance data from 28 C. auris samples and other supporting analytical studies. Findings indicate that the system reliably identifies C. auris 100% of the time.

In the future, FDA plans to propose exempting certain mass spectrometry microorganism identification system processes from additional premarket review after a system process receives a first-time FDA marketing authorization.

FDA Authorizes First Continuous Glucose Monitoring System That Can Be Integrated With Other Devices

Dexcom has received Food and Drug Administration authorization through the de novo premarket review pathway to market the Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose levels in children age 2 or older and adults with diabetes. This is the first continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices such as insulin pumps. The Dexcom G6 is a patch device that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every 5 minutes to a compatible display device and triggers an alarm when a patient’s blood sugar levels are too high or low. If the Dexcom G6 is integrated with an automated insulin dosing system, it triggers the release of insulin from the pump in response to a rise in blood sugar.

FDA Clears Cancer Genetics’ Tissue of Origin Test

Cancer Genetics has received 510(k) clearance from the Food and Drug Administration for its Tissue of Origin (TOO) test following modifications made to test reagents and software. TOO is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin and aid in classifying metastatic, poorly differentiated, or undifferentiated cancers. TOO assesses 2,000 individual genes, covering 15 of the most common tumor types (representing 58 morphologies) and 90% of all solid tumors. These tumors include thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate. Compared to the first version of the test, the current TOO assay uses new labeling reagents and has a higher accuracy rate and shorter workflow with similar precision and reproducibility. TOO is covered by Medicare and provides a pathologist’s review and interpretation of a patient’s test results and diagnosis.

Curetis Earns FDA OK for Lower Respiratory Tract Infections Test

The Food and Drug Administration (FDA) has granted Curetis de novo authorization for the use of the Unyvero system and Lower Respiratory Tract Infection (LRT) application cartridge, which together provide rapid infectious diseases testing with a focus on lower respiratory tract infections. According to Curetis, the Unyvero system identifies the causative pathogen in more than 90% of hospitalized patients with pneumonia and detects genetic antibiotic resistance markers as well. It is also the first automated molecular diagnostic test authorized by FDA for the detection of the atypical microorganism Legionella pneumoniae. Using aspirate samples, the test provides results in less than 5 hours. As part of Curetis’ FDA application for the Unyvero system and LRT, the company submitted data from a clinical trial that included more than 2,200 patient samples at nine participating U.S. hospitals. Curetis now intends to apply for a label claim extension for the LRT that would include the bronchial lavage sample types, as well as several additional diagnostic targets.