The Food and Drug Administration (FDA) is tasked with ensuring the safety and efficacy of drugs, biologics, and medical devices. If you’re developing new medical technology, the FDA regulatory process for medical devices looms large on your path to market.
Since you’re reading about the 510(k) process, you’ve probably already determined:
- The FDA considers your device to be a medical device.
- The FDA classification for your new medical device.
If you’re unsure about your device’s classification, you can use the FDA product classification database or Pathsurveyor, a free tool created by in2being, for your research. These services can provide the clarity you need to move forward with confidence.
The path to market for most Class II devices is a 510(k) submission. There are three types of 510(k) submissions:
- Traditional 510(k)
- Special 510(k)
- Abbreviated 510(k)
In this article, we’ll cover how to determine which type of 510(k) is appropriate for your medical device and the requirements and timeline for each type.
When Is a 510(k) Premarket Notification Necessary?
In general, Class II medical devices need to be cleared through the 510(k) process. Most Class I devices are exempt from the 510(k) and premarket approval (PMA) processes, and most Class III devices need a PMA.
More specifically, a 510(k) premarket notification submission is required for:
- A Class I or Class II device that is not exempted from the premarket notification process
- A Class III device categorized as a preamendment device—a device marketed prior to the passage of the medical device amendments to the Food, Drug, and Cosmetics (FD&C) Act in 1976—and not subject to the premarket approval (PMA) process
The FDA description of a specific product code provides valuable information on the exemptions and general and special FDA controls that apply to a particular device. Having a knowledgeable industry professional review and confirm your device classification is a good practice. For added assurance—or if you’re unsure of your device classification—consider filing a 513(g) request for the FDA’s opinion on your classification.
510(k) Process Summary
The 510(k) process was established in 1976 through the medical device amendments to the FD&C Act. Until 1998, there was only one type of 510(k) submission, the traditional 510(k). In 1998, the FDA created two additional types of 510(k) submissions to conserve agency resources and reduce the regulatory burden on medical device developers in certain circumstances. The two new 510(k) pathways established in 1998 are the special 510(k) and the abbreviated 510(k).
Regardless of 510(k) type, FDA clearance through the 510(k) process hinges on proving substantial equivalence to a predicate device. A predicate device is a legally marketed (already FDA-cleared) device. Your 510(k) submission is a detailed comparison of your new medical device with a carefully chosen predicate device. The goal is to prove that your new device is safe and effective by demonstrating its substantial equivalence to the safe, effective, and already cleared predicate.
The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence:
- Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device.
- Special 510(k): Prove substantial equivalence to your own previously cleared device.
- Abbreviated 510(k): Prove substantial equivalence via compliance with FDA device-specific guidance documents, FDA special controls, or consensus device-specific standards.
Traditional 510(k) submissions are far more common than any other 510(k) type. For example, in the last quarter of 2022, the FDA cleared 723 traditional 510(k) submissions (85.5%), 106 special 510(k) submissions (12.5%), and 16 abbreviated 510(k) submissions (2%).
FDA Traditional 510(k) Requirements
A 510(k) submission is not a filled-out form; it’s an organized presentation with required sections. The FDA provides detailed guidance on how to prepare a 510(k) submission and what to include. The main components of a traditional 510(k) are:
- A cover letter
- A table of contents that includes page numbers for each section
- The 510(k) acceptance checklist for the type of 510(k) (traditional, special, or abbreviated)
- A description of the device’s indications for use and intended users
- A summary of your substantial equivalence argument
- A certification of the truth and accuracy of your submission
- The proposed labeling for your device
- Device specifications, including a written description, diagrams and illustrations, and engineering drawings
- A detailed comparison of your device and the predicate device to establish substantial equivalence
- Performance data, including results from nonclinical and clinical testing
- Any additional items required for your particular device type
There are only two possible outcomes of a 510(k) submission:
- A determination of substantial equivalence (SE)
- A determination that your device is not substantially equivalent (NSE) to the predicate device
An NSE determination is considered final. In other words, if the FDA responds to your 510(k) with an NSE determination, you can’t revise your application and resubmit it. The path forward after an NSE determination is usually to either (1) prepare and resubmit a new 510(k) (possibly with a new predicate device) or (2) submit a De Novo request (see below).
Traditional 510(k) Timeline
The FDA aims to respond to all traditional 510(k) submissions with an SE or NSE determination within 90 calendar days of receipt. However, at certain points in the review process, the FDA may stop the clock on the 90-day timeline until the submitter provides additional information.
Spelled out step by step, the process looks like this:
- Within 7 calendar days, you should receive an acknowledgment of receipt from the FDA. This notice will include your submission’s unique 6-digit K number and the date the FDA received your 510(k).
- Within 15 calendar days, you should receive the results of the FDA’s initial acceptance review: accepted or refuse to accept (RTA). This initial review ensures that your submission includes all the elements required for a substantive review. If you receive an RTA notice, you’ll have 180 days to redress whatever problems the FDA had with your 510(k). The clock is stopped on your application until you submit the required information.
- Once your submission is accepted, it moves into the substantive review phase. Within 60 calendar days of receipt, the FDA will contact you for what it refers to as substantive interaction. Substantive interaction involves either (1) an interactive review that answers any FDA questions through emails or phone calls, or (2) an additional information (AI) request. If you receive an AI request, you have 180 days to submit the required information, and your 510(k) is put on hold until you do so.
- Within 90 calendar days of the FDA’s receipt of your 510(k), you should receive an SE or NSE determination. If the FDA finds your new medical device substantially equivalent to the predicate, you are legally cleared to market it.
FDA Special 510(k) Requirements
A special 510(k) offers an expedited pathway to market if you’ve made changes to your own previously cleared device that are substantial enough to warrant a new 510(k) submission. A special 510(k) aims to prove substantial equivalence to your previously cleared device.
The FDA special 510(k) guidance document sets out the requirements for using a special 510(k). The submission must be for a device that is an altered version of your own previously cleared predicate device. If it’s not, you can’t use a special 510(k). If performance data are needed to evaluate the changes to the predicate, there must be a well-established way to evaluate the changes, and it must be feasible to review the data in a summary format.
When submitting a special 510(k), your company’s design controls—the practices and procedures that ensure your device meets user needs, intended uses, and design specifications—play an important role in establishing substantial equivalence.
Here’s a checklist for the contents of a special 510(k):
- A cover letter
- The names of the predicate and modified devices
- A description of the modified device
- A comparison of the modified device with the cleared predicate
- The indications for use
- The proposed product labeling
- A description of the changes that triggered a new 510(k) submission
- A comparison of the modified and predicate devices in tabular format
- Clean and redlined documents that have been updated from the predicate’s clearance submission
- Changes to the modified device that did not warrant a new 510(k) submission
- A summary of design control activities, including risk analysis and verification and validation procedures, and how they establish substantial equivalence to the predicate device
- A statement from the individual(s) responsible for design control certifying verification and validation results and compliance with all statutory design control procedural requirements
Special 510(k) Timeline
A special 510(k) is less burdensome to prepare than a traditional 510(k), and it has the added advantage of a compressed timeline: The FDA reviews and responds to special 510(k) submissions within 30 calendar days of receipt.
If the FDA determines that your new medical device does not qualify for clearance through a special 510(k), your submission will automatically be converted to a traditional 510(k). This typically results in an RTA notice, because a special 510(k) does not include all the required contents for a traditional 510(k). Bear this in mind if you’re considering a special 510(k).
FDA Abbreviated 510(k) Requirements
The abbreviated 510(k) is the least utilized of the three 510(k) types, yet, in some instances, it may be easier to prepare than a traditional 510(k) in some instances.
Rather than using a predicate device to establish substantial equivalence, an abbreviated 510(k) relies on one or more of the following:
- Summary reports that describe how device-specific FDA guidance documents were used to establish substantial equivalence to an established device type.
- Summary reports that demonstrate compliance with device-specific special controls.
- A declaration of conformity (DOC) to voluntary consensus standards from any of 32 standards organizations (e.g., ISO, ANSI, IEEE). The FDA provides a database of recognized consensus standards.
Except for the required summary reports or DOC, the elements of an abbreviated 510(k) are the same as those of a standard 510(k).
Abbreviated 510(k) Timeline
Although its name seems to indicate otherwise, the response time for an abbreviated 510(k) is 90 calendar days, just like a traditional 510(k).
Which Type of FDA Submission is Best?
The best type of 510(k) submission for your new medical device is the one that’s least burdensome to prepare and gets your device to market soonest.
First, you can easily determine whether the special 510(k) route is an option for your company, because to use a special 510(k), you must be applying for a modified version of a previously approved device that you own. If you qualify for a special 510(k), it’s probably the best path to market for your device.
If you don’t qualify for a special 510(k), you’ll have to choose between traditional and abbreviated 510(k) submissions. Choosing between these two options comes down to a judgment call: Is it easier to demonstrate substantial equivalence to a predicate device, or is there a guidance document, special control, or consensus standard that you can use to show substantial equivalence?
Alternatives to the 510(k) Program
Not all medical devices require a 510(k). Below, we briefly describe some other common types of FDA submissions.
No Clearance Needed
First, if your research indicates that the FDA doesn’t consider the product a medical device, your path to market is much simpler—no clearance is needed.
But even some products that the FDA does consider to be medical devices are exempted. For the most part, exempted devices are low-risk Class I products, but a few Class II devices are also exempted.
Exempt Class I medical devices must comply with the FDA’s general controls. Exempt Class II devices need to comply with general and special controls.
Premarket Approval (PMA)
Class III medical devices pose the highest risk to users; therefore, they are subject to the FDA’s most stringent regulatory process, the PMA process. FDA approval through the PMA process, which typically requires human clinical trial data, is the most expensive and burdensome path to market for a medical device.
De Novo Classification
By law, all new medical devices are automatically placed in Class III and subject to the PMA process. The 510(k) process allows medical device developers to avoid the PMA process by demonstrating substantial equivalence to a predicate device. But what if there’s no appropriate predicate device for your new product?
The solution is a De Novo submission, a formal request for the FDA to reclassify a novel medical device from Class III into Class I or II. This involves presenting evidence demonstrating that the risk posed by your device does not warrant its placement in Class III. If the FDA grants your De Novo request, your product is ready to market. A De Novo request may be the best option if you receive an NSE letter in response to a 510(k) application.
Reach Out to in2being for FDA 510(k) Guidance
in2being is a full-service medical technology consultant. We partner with med-tech innovators to support the medical device development process from start to finish. Our services include help with design, engineering, prototyping, laboratory testing, intellectual property concerns, and wading through the FDA regulatory system.
Contact us today to learn more about how we can help you through the 510(k) process, no matter which type of 510(k) you need.