Pre-Market Notification – 510(k)

What is a Premarket Notification (510(k))?

A Premarket Notification (510(k)) submission is required to demonstrate that a new medical device is at least as safe and effective as a legally marketed device with the same intended use and similar technological characteristics (or that any differences do not raise new safety or effectiveness concerns). That is, the new medical device is shown to be substantially equivalent to the legally marketed predicate device. 510(k)s are required for most devices that are not exempt from premarket review, typically most Class II medical devices and some Class I medical devices.

A 510(k) submission is required for devices never marketed in the U.S. before (new devices) that are not exempt from premarket review and for FDA-cleared devices with a significant change that could affect safety or effectiveness, such as design, materials, energy source, manufacturing process, or indications for use.

How to Prepare a 510(k)?

A Premarket Notification (510(k)) for a new device should include the following information:

• 510(k) cover letter
• Applicant Information
• List of Standards to which the device complies.
• Device description, including type of device, indications for use, materials and performance specifications, including engineering drawings and photographs of the device. Device components and accessories should also be described.
• Indications for Use (IFU) Statement, including purpose and function of the device, intended environments, and all device claims.
• Device Classification, including the medical specialty, the 21 CFR classification code and relevant device product codes.
• Predicates and Substantial Equivalence Comparison. Comparison of the device to a predicate device/s, describing the similarities and differences in materials, design, technology, specifications, indications for use and performance characteristics. Labeling and/or promotional material describing the predicate device/s specifications, intended use, etc., is helpful in preparing this section.
• Proposed Labeling should include complete instructions for use, package labeling and any promotional material, which describes the system features, specifications, and intended use. Labeling material must comply with FDA guidelines and standards.
• Reprocessing, Sterility and Shelf-Life information including the sterilization methods for the device and/or components must be submitted (if relevant), including sterilization validation methods, shelf-life testing, packaging validation, etc. Additionally, appropriate instructions should be provided regarding the cleaning, disinfection or re-sterilization methods for reusable components of the device, if applicable.
• Biocompatibility testing or statement of patient contact materials/ fluid path contact materials. The materials that come in direct contact with the human body must be shown to be biocompatible according to the FDA Guidelines; Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices 5/1/95 (G95-1) and/or the ISO 10993 Biocompatibility Standard.
• • Software validation documentation should be included in the submission, including the following information, as applicable:

  -Software Risk/Hazard Management File and Risk Analysis;

  -Software/Firmware Description

  -Software Requirements Specification (SRS) Document

  -Software Design Document (SDD) Document;

  -Software Test Plan (STP) and/or Description (STD) Document;

  -Software Test Reporting Form (STR); or Summary of Test Results;

  -List of Unresolved Anomalies

  -Software Version History

  -Cybersecurity Procedure and Reports

  -Software Lifecycle Procedure

  Additional documents may be required depending on the risk level of the device.

  • Electromagnetic Disturbances and Electrical Safety testing of the device according to FDA recognized standards for electrical and mechanical safety (IEC 60601-1) and Electromagnetic Disturbances (IEC 60601-1-2) should be included, as applicable.
  • Performance Testing – bench testing that assures repeatable performance of the device to specifications should be provided. Performance testing may include testing of the new device with in-house bench tests, testing according to international standards, or testing according to FDA Guidance documents. For each performance test, a detailed test protocol with pass/fail criteria, test results including raw data, and a report of the test results which complies with FDA guidelines and standards should be included.
  • Animal Testing – a detailed non-clinical study protocol, study results including raw data, and a report of the study results which complies with FDA guidelines and GLP standards should be included, as applicable.
  • Clinical Testing – a detailed clinical study protocol, study results including raw data, and a report of the study results which complies with FDA guidelines and standards should be included, as applicable.

• Administrative Documentation, including the following:

-Executive Summary – a summary of the 510(k) submission

-Truthful and Accurate Statement – a statement by the 510(k) submitter that the information provided in the 510(k) is truthful and accurate.

-510(k) Summary or 510(k) Statement – A Summary of Safety and Effectiveness should be prepared for submission in the 510(k) document. The Summary includes a general description of the device, its indications for use and a brief summary of the basis for substantial equivalence. The 510(k) Summary will be publicly available once the 510(k) is cleared.

-Medical Device User Fee (Form FDA 3601) – payment to the FDA must be remitted prior to the 510(k) submission to FDA. The 2026 user fee for a 510(k) is $26,067 (small business fee is $6,517). If the company qualifies as a small business, they should apply for this qualification at least 60 days prior to the 510(k) submission.

-Declaration of Conformity – a declaration of conformity of the subject device with the list of standards provided in section 3.

-Financial Certification and Disclosure statement, if applicable.

-Clinical Trials Certification Form (Form FDA-3674), if applicable.

FDA Guidelines for the preparation and format of a 510(k) can be found on the following website – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.

Helpful tips when submitting a 510(k):

• All 510(k) submissions must be prepared and submitted using the electronic Submission Template and Resource (eSTAR) format to ensure standardized formatting and faster processing. The eSTAR guidance and format may be found at https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program.
• FDA discourages, and in some cases effectively limits, the use of multiple predicates or “split predicates” to demonstrate substantial equivalence for a single device.
• A 510(k) may require supportive data, in the form of non-clinical (bench or animal testing) or clinical data to support substantial equivalence, if the device has differences in intended use, technological characteristics, materials, or performance that could affect safety or effectiveness.
• A Special 510(k) is appropriate when modifications to a legally marketed device are minor and do not affect safety or effectiveness in a way that would require new testing, and the change can be evaluated through risk analysis, design controls, and a documented verification/validation approach for the modification. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program)
• Early FDA engagement is advisable, especially if the 510(k) regulatory pathway is not straightforward. This may be done using the Pre-sub/Q-sub option. Subsequent, Pre-Sub meetings can clarify expectations, reduce cycles, and help align the data requirements and testing plans.
• When drafting the 510(k) Summary of Safety and Effectiveness (SSE), ensure that no confidential commercial information or trade secrets are included, as this summary will become publicly accessible following FDA clearance.

How we can help?

1. Stein – Regulatory Affairs Consulting has prepared and submitted hundreds of Premarket Notifications (510(k)s) and obtained successful clearances for a wide range of medical devices from catheters to MRI devices, including diagnostic and therapeutic devices, as well as AI driven devices.