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FDA Watch: Simplifying and Speeding Up 510(k) Authorization

by | Oct 20, 2023 | Essential, FDA-lir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

What lab leaders need to know about the FDA’s three new 510(k) draft guidances.

Getting FDA premarket authorization for a new in vitro diagnostic test or medical device via the 510(k) pathway takes a long time. You must submit a premarket notification to the FDA at least 90 days before introducing the new device to the market for commercial distribution, demonstrating that the product is substantially equivalent to a “predicate device” that’s currently on the market in terms of use, technology, safety, and health.1 Then, you have to wait months for the agency to respond to your submission. The good news is that the FDA recently issued new draft guidance aiming to speed up and simplify the 510(k) authorization process. Here’s a summary of the three different draft guidances that the agency published on September 7:

FDA Objectives for Speeding Up 510(k) Authorization

The FDA has acknowledged that the current 510(k) process is too slow. As part of the Medical Device User Fee Amendments (MDUFA V) agreement concluded with the medical device industry in 2022, the FDA committed to cut the average “total time to decision” for 510(k) submissions to:2,3

    • 128 calendar days in FY 2023

    • 124 calendar days in FY 2024

  • 112 calendar days in FY 2025, 2026, and 2027


The first guidance tells manufacturers how to select an appropriate predicate device to compare their product to in the 510(k) submission.4

Best Practice: Base your selection on the quality of evidence used to clear the predicate device, as well as the device’s performance history, paying close attention to any unresolved safety issues and design-related recalls.

Look for a predicate device that:

    1. Was cleared using “well-established methods,” including an “FDA-recognized voluntary consensus standard, FDA guidance document, qualified medical device development tool (MDDT), or a widely available and accepted method published in the public domain or scientific literature4

    1. Continues to meet or exceed safety standards, giving consideration to recalls, adverse events, and material changes that occurred after the device reached the market

    1. Doesn’t have “unmitigated use-related or design-related safety issues,” based on “consideration of emerging signals or safety communications”4

  1. Hasn’t been subject to a design-related recall


The second draft guidance tells manufacturers what data to use in the 510(k) submission to demonstrate that their product is as safe and effective as the predicate device.5

Best Practice: Use valid scientific evidence from “well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device.”6

Forms of valid scientific evidence to use include (without limitation):

    1. Results of pre and postmarket clinical investigations of the device

    1. Results of pre and postmarket clinical investigations or other studies of comparable devices reported in the scientific literature

    1. Unpublished reports about the clinical experience of the new device or a comparable device

  1. Registries, adverse event databases, medical records—such as electronic health records or claims—and other sources of data about the device or predicate device’s clinical performance


The third draft guidance sets out evidentiary expectations for implant devices under the 510(k) process. The Federal Food, Drug, and Cosmetic Act regulations (21 CFR 860.3(d)) define an implant as “a device that is placed into a surgically or naturally formed cavity of the human body” for 30 days or more. Accordingly, this draft guidance has only limited relevance to laboratory tests.7


    1. https://uscode.house.gov/view.xhtml?req=(title:21%20section:360c%20edition:prelim)

    1. https://www.g2intelligence.com/congress-passes-new-fda-medical-devices-user-fee-amendments-mdufa-v-deal/

    1. https://www.fda.gov/media/157074/download

    1. https://www.fda.gov/media/171838/download

    1. https://www.fda.gov/media/171837/download

    1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=860.7

  1. https://www.fda.gov/media/171835/download


Here are the key new FDA clearances that were announced in the period from mid-August through early October 2023:

New FDA Approvals and Emergency Use Authorizations (EUAs)

Manufacturer(s) Product
Sanguina 510(k) clearance for AnemoCheck Home self-test for those with anemia to monitor hemoglobin levels
EntroGen Premarket approval for CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted colorectal cancer therapy
ProciseDx De Novo clearance for therapeutic drug monitoring tests for adalimumab (Humira® and biosimilar Amgevita®) and infliximab (Remicade® and biosimilars Inflectra® and Renflexis®)
Tangen Biosciences EUA for TangenDx SARS-CoV-2 Molecular Test
SD Biosensor EUA for STANDARD Q COVID-19 Ag Test 2.0 lateral flow immunoassay to detect nucleocapsid protein antigen from SARS-CoV-2
Invitae De Novo clearance for Common Hereditary Cancers Panel, a DNA sequencing test identifying variants in 47 genes associated with elevated risk of various cancers
Streck Clearance for MDx-Chex® quality controls to verify performance of Luminex® VERIGENE® Blood Culture Gram-Positive and Gram-Negative tests for bloodstream infection and sepsis
3EO Health EUA for 3EO Health COVID-19 Test, an over-the-counter, at-home molecular COVID-19 test
Cepheid (subsidiary of Danaher) 510(k) clearance for Xpert Xpress CoV-2/Flu/RSV Plus RT-PCR test for qualitative detection and differentiation of SARS-CoV-2, influenza A/B, and respiratory syncytial virus infections
Thermo Fisher Scientific 510(k) clearance for Sensititre™ YeastOne™ Susceptibility System with Rezafungin in the dilution range of 0.008–8 µg/ml, which is used to test for susceptibility of Candida species.
Thermo Fisher Scientific 510(k) clearance for Sensititre 20-24-Hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml for susceptibility testing of fastidious isolates
Thermo Fisher Scientific 510(k) clearance for Sensititre 18-24-Hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 µg/mL for susceptibility of non-fastidious organisms
Zeus Scientific 510(k) clearance for ZEUS IFA™ nDNA Test System, an indirect immunofluorescence assay to aid in diagnosis of systemic lupus erythematosus
QuidelOrtho CLIA waiver for Sofia® 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay for COVID-19 antigen detection
T2 Biosystems 510(k) clearance for T2Biothreat Panel detecting organisms that cause anthrax, tularemia, glanders, melioidosis, plague, and typhus

New CE marks and global certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s) Product(s)
ZeptoMetrix IVDR certification for majority of firm’s CE-marked ZeptoMetrix NATtrol™ quality control products
Medtronic New version of company’s Simplera continuous glucose monitor
Moon Surgical New version of company’s Maestro surgical robotics system

Other international clearances announced during the period:

Manufacturer(s) Country Product(s)
Bionano (via its Chinese original equipment manufacturer partner, Ecobono) China SP-G2 DNA isolation kit
MGI Tech China DNBSEQ-G99 sequencer

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