What Should be Included in a 510(k) Submission?

As the most frequent premarket submission in the USA for medical devices, Regulatory professionals must navigate the FDA 510(k) submission process effectively.

Here’s an expert rundown on the critical elements for a 510(k) submission:

• Classifying device risk levels
• Demonstrating substantial equivalence to existing devices
• Choosing the appropriate 510(k) submission type
• Assembling a thorough submission package
• Leveraging previous 510(k) submissions for strategic insights

Risk-Based Device Classification

FDA classifies devices by risk into three categories:

• Class I: Low-risk and generally exempt from premarket notification.
• Class II: Moderate-risk, usually requiring premarket notification.
• Class III: High-risk, typically necessitating premarket approval rather than premarket notification

[Related: Click here to view a sample 510(k) submission and see what one medical device firm included in its 510(k) submission.]

Why is it called a 510(k)?

The name 510(k) refers to the 510(k) section of the Federal Food, Drug and Cosmetic Act. For an outline of 510(k) submission requirements, review 21 CFR 807 subpart E.

When is a 510(k) Necessary?

A 510(k) submission is mandatory when:

• Introducing a new device to the market.
• Changing the intended use of an existing cleared device.
• Making significant changes to an already cleared device.

Device Classifications

FDA regulates medical devices based on risk. There are three classes of medical devices:

• Class I:
  • Low-risk devices
  • Subject to general controls
  • Most are exempt from premarket notification process
• Class II:
  • Moderate-risk devices
  • Subject to general and special controls
  • Most require premarket notification
• Class III:
  • High-risk devices
  • Subject to general controls and premarket approval

Most product codes are found on all 510(k) clearance letters. These can be useful when searching for relevant products that have similar codes (keep reading to learn more about searching 510(k) clearance letters).

Types of 510(k) Submissions

There are three pathways for a 510(k) submission:

• Traditional: The standard approach for all scenarios, based on showing substantial equivalence to a predicate device.
• Abbreviated: For cases meeting specific criteria, utilizing existing guidance and standards.
• Special: For modifications to a manufacturer’s own device that don’t alter its intended use or fundamental technology.

FDA has provided helpful checklists to use when preparing your 510(k).

Components of a 510(k) Submission

Your 510(k) submission should be comprehensive, containing:

• A table of contents that’s easy to navigate.
• All necessary administrative information, including forms, cover letters, and the FDA’s eSubmitter application if applicable.
• Definitions of the device’s intended use, specifying if it’s for prescription or over-the-counter application.
• A concise 510(k) summary.
• An in-depth device description with visuals, material specifics, and technical details.
• A persuasive argument for substantial equivalence to a predicate device.
• Proposed device labeling that adheres to 21 CFR 801 regulations, encompassing all instructional materials, promotional content, and any manuals.
• Complete performance testing data, with methodologies, acceptance criteria, and results clearly presented.
• Incorporating FDA’s eSTAR Program

The FDA has introduced the electronic Submission Template And Resource (eSTAR) program to streamline the review of 510(k) submissions. eSTAR is an interactive PDF template designed to assist in creating and submitting a premarket notification (510(k)) application. Using eSTAR can simplify the submission process as it:

• Guides you through the preparation of the submission package.
• Helps ensure completeness and consistency of the submission content.
• Facilitates a more efficient review process by the FDA due to the standardized format.

It’s recommended to utilize the eSTAR template for assembling your submission, as this can potentially expedite the FDA’s review time by providing a structured and predictable submission format.

Substantial Equivalence and Predicate Devices

A 510(k) is based on the determination of Substantial Equivalence; it is the entire point of a 510(k). 510(k) submissions can be hundreds of pages long, if necessary, to demonstrate Substantial Equivalence. A successful 510(k) will result in FDA clearance. Note that 510(k) clearance does not indicate FDA approval – it is simply FDA cleared.

Substantial Equivalence requires the use of a predicate (comparable) device to demonstrate that the device in review has the same intended use and technological characteristics. Predicate devices are legally marketed devices that have been, typically, cleared through the 510(k) process already. Note that differences in technological characteristics may be allowed if these characteristics do not indicate or raise questions of safety and effectiveness.

Premarket reviewers consult a 510(k) decision-making flowchart when assessing Substantial Equivalence. Those producing a 510(k) submission would be wise to review the chart and make sure they address every decision point (link below).

The following documents regarding Substantial Equivalence and predicate devices should be read:

• Evaluating Substantial Equivalence in Premarket Notification (you can find the flowchart in Appendix A)
• How to Find and Effectively Use Predicate Devices

Here are a few additional notes on the subject:

• Multiple predicate devices are only acceptable under certain circumstances. Refer to the 510(k) final guidance to know when this is appropriate. Also, split predicates are inconsistent with the 510(k) regulatory standard.
• Reference Devices may also be used to support scientific methodology or standard reference values. Note that these are not predicate devices.
• If after due diligence no identifiable predicate device is known, you may want to consider a de novo.

Researching FDA Regulation, Summaries, and Previous 510(k) Submissions

Begin at the FDA’s medical device premarket notification page, which provides information on cleared devices and access to detailed device summaries.

Analyzing previously cleared 510(k) submissions, like those available from Redica Systems, can provide valuable examples to guide your submission process.

Viewing a sample 510(k) that has already been submitted can also be valuable. Redica Systems offers a free sample 510(k) that can be downloaded here. This sample 510(k) includes FDA correspondence, amendments, and reviewer information. Medical device manufacturers can use this sample 510(k) as a guide for their next submission.

For Questions

FDA recognizes that preparing a 510(k) can be complex and confusing. To that end, the Center for Devices and Radiological Health (CDRH) has established the Division of Industry and Consumer Education (DICE), which offers help in resolving medical device questions and generally responds to questions within two working days. Contact information is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice.

The same page also offers a link to “Device Advice” which addresses the most commonly asked questions about device definition, how to study and market a device, user fees, device registration and listing, and online training for the medical device industry.