Home 5 Clinical Diagnostics Insider 5 The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices

The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices

by | Oct 30, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.

On September 7, the FDA published three draft guidances proposing fundamental alterations to the 510(k) pathway it uses to clear in vitro diagnostic tests and other medical devices. The changes aim to speed up the process and place less emphasis on older predicate products in deciding whether to grant premarket clearance to new devices, while still ensuring products’ safety.

The diagnostic challenge

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to submit a premarket notification to the FDA at least 90 days before introducing a new device intended for human use to the market for commercial distribution. The manufacturer must demonstrate in the 510(k) marketing submission that the device is substantially equivalent to a “predicate device” in accordance with section 513(i) of the FD&C Act by essentially comparing the two devices in terms of use, technology, safety, health, and other criteria listed in the statute. The agency then reviews the submission to determine whether the product meets the criteria for market clearance.1

The issue with this approach is that predicate devices may be decades old, considering that the FDA has been clearing medical devices since 1976. “Data show that nearly 20 percent of current 510(k) [clearances] are based on a predicate [device] that’s more than 10 years old,” according to the agency.2 In 2018, the agency issued a Medical Device Safety Action Plan for updating the 510(k) pathway to account for advances in medical technology. “As device technology continues to evolve and the types of medical devices expand exponentially, we are mindful that the ways in which we assure reasonable device safety must also keep pace,” the plan noted.3

The new FDA 510(k) draft guidance

The three new draft guidances are the culmination of more than five years of FDA 510(k) modernization efforts, covering:

1. Selection of predicate devices

The draft guidance on selection of predicate devices for use in a 510(k) premarket submission comparison asks manufacturers to base their selection on the quality of evidence used to clear those predicate devices, as well the devices’ performance history since entering the market, especially in terms of unresolved safety issues and design-related recalls.4

Recommended best practices: Manufacturers should use the agency’s FDA 510(k) Premarket Notification Database to gather basic information necessary to identify potentially valid predicate devices that may serve as the basis of comparison, including but not limited to the trade names, manufacturers, and 510(k) numbers of similar devices. In selecting the predicate device, manufacturers should look for:5

  • devices that were cleared using “well-established methods,” including those from 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 literature”;
  • devices that continue to meet or exceed safety standards during use in their intended environment, giving consideration to recalls, adverse events, and material changes that occurred after the device reached the market;
  • devices that do not have “unmitigated use-related or design-related safety issues,” based on “consideration of emerging signals or safety communications”; and
  • devices that have not been subject to a “design-related recall.”

2. Use of clinical data

The draft guidance on use of clinical data says that data to support a 510(k) notification should constitute “valid scientific evidence,” which may include, but aren’t limited to:6

  • results of pre and postmarket clinical investigations of the device, i.e., clinical trials;
  • results of pre and postmarket clinical investigations or other studies of comparable devices reported in the scientific literature;
  • unpublished reports about the clinical experience of the new device or a comparable device; and
  • 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 draft guidance also lists detailed scenarios illustrating situations when manufacturers must back their 510(k) submissions with clinical data demonstrating the equivalence of the new device to an existing predicate. An example of such a situation is when there are technological differences between the devices or nonclinical testing alone is inadequate to establish equivalence.

3. Evidentiary expectations for implant devices

The third draft guidance sets out evidentiary expectations for implant devices under the 510(k) process. The FD&C 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


Issuing draft guidances is an “important step in our ongoing commitment to optimize the clarity, predictability, and consistency of the 510(k) Program,” noted Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in a statement accompanying the release of the proposals.8 The initiative also advances the FDA’s efforts to implement its commitment under the 2022 Medical Device User Fee Amendments (MDUFA V) agreement to cut the time the agency takes to decide on 510(k) submissions from the current 128 calendar days to 112 calendar days by 2027. The agency’s ultimate objective is to eventually issue decisions on 95 percent of submissions within 90 days.9,10

The FDA will be taking public comments on the new draft guidance materials through December 6. It will then finalize the guidances based on the feedback.


  1. https://uscode.house.gov/view.xhtml?req=(title:21%20section:360c%20edition:prelim)
  2. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and
  3. https://www.fda.gov/media/112497/download
  4. https://www.fda.gov/media/171838/download
  5. https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database
  6. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-use-clinical-data-premarket-notification-510k-submissions
  7. https://www.fda.gov/media/171835/download
  8. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program
  9. https://www.fda.gov/media/157074/download?attachment
  10. https://www.g2intelligence.com/congress-passes-new-fda-medical-devices-user-fee-amendments-mdufa-v-deal/


Here are the key new laboratory testing and diagnostic product clearances that were announced in the period between mid-August 2023 and early October 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s) Product
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
Princeton BioMeditech EUA for ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test for simultaneous detection and differentiation of SARS-CoV-2, influenza A, and influenza B
23andMe 510(k) clearance to report 41 additional variants in the BRCA1 and BRCA2 genes linked to risks of breast, ovarian, prostate, and pancreatic cancers
Quest Diagnostics Breakthrough Device designation for AAVrh74 ELISA assay as companion diagnostic to identify patients eligible for treatment with Sarepta Therapeutics’ ELEVIDYS® (delandistrogene moxeparvovec-rokl) gene therapy for Duchenne muscular dystrophy
LivaNova 510(k) clearance for Essenz™ In-Line Blood Monitor (ILBM)

New CE marks and global certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s) Product(s)
Medtronic New version of company’s Simplera continuous glucose monitor
Moon Surgical New version of company’s Maestro surgical robotics system
LivaNova Essenz™ In-Line Blood Monitor (ILBM)

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
Genedrive UK Genedrive® CYP2C19 System to identify stroke patients likely to respond to clopidogrel treatment by testing for six genetic variants of CYP2C19 gene affecting loss of metabolism function and poor activation of clopidogrel
Guardant Health Japan Guardant360® CDx liquid biopsy test as companion diagnostic to select patients with unresectable advanced or recurrent, HER2-mutant non-small cell lung cancer for treatment with Daiichi Sankyo’s antibody drug conjugate ENHERTU® (trastuzumab deruxtecan)

Subscribe to Clinical Diagnostics Insider to view

Start a Free Trial for immediate access to this article