510(k) 101

Premarket Notification, also referred to as 510(k), is a premarket submission made to FDA for certain moderate risk products. The 510(k) process is the most common avenue of premarket submission for medical devices. This article provides a high-level understanding of the content required in 510(k) submission and helpful resources, including:

• Device classifications
• Substantial Equivalence
• Types of 510(k) submissions
• 510(k) submission content
• 510(k) regulatory intelligence

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, the portion of that Act which allows for the premarket notification of certain medical devices.

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

Determination of the proper product classification, and therefore your device’s premarket regulatory submission requirements starts with analysis of FDA’s regulation, product codes, and similar marketed products. Product classifications and product code determinations are proposed by the sponsor within the 510(k) submission and confirmed or modified by the FDA during the 510(k) review process.

[Want to take a look at a 510k? You can download one instantly here.]

When is a 510(k) required?

A 510(k) submission is required for a “new device” within the meaning of section 201(h) of the FD&C act. This is a device that is not yet legally marketed; it may be a completely new device or a modification of a legally marketed device requiring a new 510(k). In other words, a 510(k) is required when: 

• 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. Traditional 510(k) submissions ,ay 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 510(k) submissions are used when making modifications to your own previously cleared product. A Special 510(k) may only be utilized when modifications do not affect the intended use or the fundamental technology of the device.

FDA has an interactive PDF form that guides applicants through the process of preparing a 510(k) which can be found here; Voluntary eSTAR Program | FDA

Substantial Equivalence and Predicate Devices

The 510(k) submission is made to FDA to demonstrate that the subject device is “substantially equivalent” to a legally marketed device. In the submission, the sponsor compares their device to the legally marketed “predicate device” to demonstrate that:

•  the subject device has the same intended use as the predicate and 
•  The subject device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device.

510(k) submissions can be hundreds of pages long, if necessary, to demonstrate Substantial Equivalence. A successful 510(k) will result in FDA clearance. 

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.

Sponsors have many guidance documents to rely on for the content and format of 510(k) submissions. A thorough collection and analysis of all of the applicable regulations, guidance, standards, and product regulatory data should be performed when planning for and submitting a 510(k). 

510(k) Regulatory Intelligence

510(k) regulatory intelligence refers to the collection, analysis, and utilization of information related to the FDA’s 510(k) premarket notification process for medical devices. This type of regulatory intelligence includes information on FDA regulations, guidance documents, and best practices related to the 510(k) process, as well as pre and postmarket data for similar products including potential predicate and reference devices. 

510(k) regulatory intelligence can include analysis of historical FDA clearance decisions, trends in the regulatory landscape, and potential compliance issues related to the 510(k) process. This information can be used to inform their product development and regulatory strategy, ensure compliance with FDA regulations, and increase the chances of a successful and stress free clearance process.

A key portion of regulatory intelligence is identification and analysis of pertinent 510(k) Summaries, Decision Summaries, and redacted 510(k) documents where available.  Redica Systems TPLC product includes over 40,000 redacted 510(k)s, which may further assist in submission strategy and benchmarking. Overall, 510(k) regulatory intelligence is an important tool when navigating the complex regulatory landscape.

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 industry.