A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a new medical device is at least as safe and effective as a comparable device already legally on the market (i.e., substantially equivalent). Manufacturers must support their substantial equivalence claims with a comprehensive set of data, typically including laboratory test results on characteristics such as sterility, shelf life, biocompatibility, and mechanical performance.
This article summarizes the 510(k) process from a practical, testing-related perspective. If you would like to know more about how Measurlabs can support your company’s premarket submission to the FDA, please contact our experts for more information.
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When is a 510(k) submission required?
A company wishing to market a new medical device in the United States must submit a 510(k) to the FDA unless the device is exempt or a Premarket Approval (PMA) application is required instead. A new submission may also be necessary when modifications are made to an existing, legally marketed device.1
In practice, the classification of the medical device will typically determine which route to market is appropriate:
Class I devices are, in most cases, exempt from the requirement to submit a 510(k) due to their low-risk profile.
Class II devices (medium risk) typically require a 510(k), although there are some exceptions listed in the FDA database of medical device exemptions.2
Class III devices (high-risk) are generally approved through the more stringent Premarket Approval process.
If there is no legally marketed predicate device with respect to which a substantial equivalence claim could be made, the De Novo classification route can be pursued instead of a 510(k).3
What types of tests are required to support 510(k) submissions?
Laboratory test results are a key form of evidence when demonstrating that medical devices are safe and effective. The following are examples of tests often required to show that performance is on a comparable level with that of the predicate device:4
Biocompatibility testing to show that patient-contacting materials do not cause unacceptable adverse reactions.
Sterility testing to demonstrate that sterile devices are free from viable microorganisms and excessive amounts of sterilizing agent residues.
Shelf-life testing to show the device retains its chemical, physical, microbiological, and other relevant characteristics throughout the intended shelf-life.
Cleaning and reprocessing validation to show that reusable devices can be cleaned and disinfected or sterilized effectively between uses.
Non-clinical bench performance testing to demonstrate that the mechanical and biological engineering performance of the device meets defined acceptance criteria.
How should testing be conducted?
The most straightforward way to conduct testing for a 510(k) submission is to follow FDA-recognized consensus standards, whenever available. While voluntary, this typically reduces both submission review time and the amount of documentation required, as a detailed description of the test procedure can be replaced with a reference to the standard.5 The FDA also generally expects nonclinical testing to be conducted in accordance with Good Laboratory Practices (GLP).6
Biocompatibility testing for 510(k) submission
The extent of biocompatibility testing required for FDA 510(k) submission depends on the category of the device, how it contacts the body, and the contact duration, with more invasive devices generally requiring more extensive testing. Endpoint selection is based on ISO 10993-1 and FDA biocompatibility guidance.
The most commonly performed tests, required for most new devices, include:7
It is worth noting that the FDA recognizes Parts 18, 10, and 23 of ISO 10993 only partially. Examples of notable sections outside the scope of recognition include in vitro sensitization tests described in Annex C to ISO 10993-10 and in vitro irritation tests described in Clause 6 of ISO 10993-23.8
FDA-recognized consensus standards for evaluating further biocompatibility endpoints include:
ISO 10993-3: Genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-6: Local effects after implantation
ISO 10993-11: Systemic toxicity testing (acute, subacute, subchronic, or chronic toxicity, depending on the duration of patient exposure)
ISO 10993-17: Toxicological risk assessment of leachables identified during chemical characterization.
ISO 18562 (Parts 1, 2, 3, and 4): Biocompatibility evaluation of breathing gas pathways, covering particulate matter, volatile organic compounds (VOCs), and leachables in condensate
Note that ISO 10993-3, ISO 10993-17, and ISO 18562-1 are recognized partially, as the FDA considers certain clauses to conflict with other standards, guidance documents, or published literature.9
Sterility testing and reprocessing validation for 510(k) submission
The most straightforward way to substantiate sterility claims for a 510(k) submission is to use one of the established sterilization methods listed by the FDA. These include dry heat, ethylene oxide (EO), steam, radiation, and vaporized hydrogen peroxide treatments.10 After sterilization, testing is needed to demonstrate that the device is free from viable microorganisms, and that sterilizing agent residues remain within safe limits.
FDA-recognized consensus standards for sterility testing include:
ISO 11737-1: Bioburden, i.e., the presence of microorganisms on the device before sterilization
ISO 11737-2: Growth of microorganisms on the device after sterilization
ISO 11737-3: Quantification of bacterial endotoxins with the Limulus Amebocyte Lysate (LAL) test
ISO 10993-7: Ethylene oxide (EO) sterilization and residuals
Reusable devices will require further tests to validate the reprocessing procedure between uses. These include cleaning, disinfection, and/or sterilization validation studies. Applicable consensus standards include ISO 17664 (Parts 1 and 2) and ANSI/AAMI ST98.
Performance testing for 510(k) submission
Mechanical performance characteristics to be assessed for premarket notifications can include, for example, fatigue, wear, tensile strength, compression, and burst pressure.11 Consensus standards are typically product-specific, which means that there are dozens of them. For example, the FDA recognizes over 40 different standards relating to fatigue testing of materials and devices in the orthopedic, cardiovascular, physical medicine, and dental categories.12
Shelf life testing for 510(k) submission
Shelf life testing typically consists of accelerated and/or real-time aging protocols and tests to evaluate relevant device characteristics, such as mechanical performance and chemical stability, at different time points throughout the aging period.13 Especially in the case of sterile devices, shelf life is closely related to the effectiveness of the packaging in maintaining an effective barrier against microbial contamination.
The following are examples of FDA-recognized standards for shelf life assessment:
ISO 11607-1 and ISO 11607-2: Tests to evaluate the packaging of terminally sterilized medical devices
ASTM F1980: Accelerated aging of medical device sterile barrier systems
ASTM F1608: Microbial ranking of packaging materials
Testing to comply with FDA premarket notification requirements
Measurlabs offers an extensive range of medical device testing services to support your company’s 510(k) submission, including all the standardized tests mentioned in this article. When applicable, nonclinical laboratory studies can be conducted under GLP to ensure that reports meet FDA expectations. For more information and a quote for your device, please contact us via the form below.
References:
1 See more in FDA Guidance Document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications.
2 Both Class I and Class II devices exempt from 510(k) submission are listed in the Medical Device Exemptions 510(k) and GMP Requirements database.
3 Read more about De Novo classification requests on the FDA website.
4 All these characteristics are included in the 510(k) Electronic Submission Template.
5 FDA Guidance Document: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices and the FDA database of Recognized Consensus Standards
6 Part 58 of chapter I of title 21 of the Code of Federal Regulations (21 CFR). The requirement to conduct testing according to GLP does not apply to “basic exploratory studies”.
7 Note that testing may not be necessary if these endpoints are addressed by existing data. See more in the FDA Guidance Document on the Use of International Standard ISO 10993-1.
8 See FDA’s partial recognition of ISO 10993-18, ISO 10993-10, and ISO 10993-23 for more details.
9 See FDA’s partial recognition of ISO 10993-3, ISO 10993-17, and ISO 18562-1 for more details.
10 FDA guidance document on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
12 Search for the keyword “fatigue” in the FDA’s Recognized Consensus Standard database on Nov. 11th, 2025.
13 FDA's Guidance Document on the Shelf Life of Medical Devices explains how shelf life can be determined.