(This was originally published on January 24, 2020.)

As pharmaceutical pipelines become tighter, more complex, and expensive, drug firms are taking a hard look at offering new delivery mechanisms and prepackaged drug/device kits. The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices.

This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process, including:

  • Device classifications
  • Substantial equivalence
  • Types of 510(k) submissions
  • What goes into a 510(k) submission
  • Researching other 510(k) submissions

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

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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.

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).

When is a 510(k) required?

510(k) is required under the following conditions:

  • Introducing a new device to the market for the first time.
  • Changing the indications for use of a previously cleared device.
  • Making significant modifications to a previously cleared device.

What Are the Types of Submissions?

There are three types of 510(k) submissions: traditional, abbreviated, and special. With all three types, the required elements of 21 CFR 807.87 must be submitted. These are administrative requirements including items like business name, etc.

Traditional submissions can be used under any circumstance. These submissions rely on the demonstration of Substantial Equivalence, which we will discuss later in this article.

Abbreviated submissions can only be used if certain criteria are met. These submissions rely on the use of guidance documents, recognized standards, special controls, etc.

Special submissions are used when you are making modifications to your own product that is a legally marketed device. Note that modifications cannot affect the intended use of the fundamental technology of the device because that data is not typically submitted with a 510(k).

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

What Should Be Submitted in Your 510(k)?

The following items are all required in your premarket notification:

  • Table of contents with appropriate paging.
  • Administrative requirements, certain forms and cover letters.
  • Intended use and indication for use, including indication of prescription use or OTC.
  • 510(k) summary.
  • Detailed device description. This can include figures, diagrams, materials (including patient-contacting materials), energy sources, technological features, etc. Note: it would be prudent to include as many visuals as possible.
  • Detailed discussion of Substantial Equivalence based on a predicate device (see section below for more information on Substantial Equivalence and predicate devices).
  • Proposed labeling for your device.
    • The proposed labeling should comply with 21 CFR 801. Copies of all labeling are recommended, including package insert, service manuals, instructions for use, advertising and promotional materials, etc. Copies of your predicate device’s labeling is recommended but not required.
  • Performance testing (bench, animal, or clinical) or comparative testing. Device-specific guidance documents may provide recommendations on appropriate performance testing. Testing should include test methods, acceptance criteria, and test results.

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:

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

Researching FDA regulation of medical devices begins at https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances, where FDA explains the medical device premarket notification submission process and offers links to listings of devices cleared for market and, sometimes, a sponsor-prepared device summary as specified in 21 CFR 807.92(c).

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.

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