All new medical devices must be either approved or cleared by the Food and Drug Administration FDA before proceeding to market. The path to FDA approval or clearance can follow two distinct routes. The PMN process outlined in Section k of the Federal Food, Drug and Cosmetic Act was intended to reduce the time and costs associated with PMA in cases where risk to health and safety is not an issue, for example, when a new medical device is very similar to a previously approved device.
The vast majority of medical devices currently gain access to the American marketplace through k process. Once the FDA is satisfied that the demonstration meets all regulatory requirements, the device is approved for marketing within the United States.
Class III devices — those that sustain life or pose a high degree of risk for injury or illness — always require a PMA, as do all devices that do not qualify under Section k. The PMA process is expensive and time-consuming. Trials must be carried out rigorously and in adequate number to prove the effectiveness and safety of a new medical device.
Each step along the way must be documented to insure validity and reliability, as well as certifying that GLP was followed. Depending on the device, this process can take years and millions of dollars. Device developers sometimes petition the FDA to change the device classification to one that does not require such stringent approval processes, such as Class I or Class II.
In other instances, they may opt for seeking clearance for marketing under Section k of the Food, Drug, and Cosmetic Act Medical Device Amendments ofwhich allows for well-documented notification of safety and effectiveness. A k clearance is only appropriate when a device is substantially equivalent to a pre-approved device. When a medical device is merely a tweak of a previously approved medical device, a minor change in function or form, or a device made up of previously approved products, the manufacturer can file a PMN under Section k.
A PMN must be field at least 90 days before a device is due to enter the commercial market, documenting its substantial equivalence to a predicate device one which has already passed FDA investigation.
The k Route When a medical device is merely a tweak of a previously approved medical device, a minor change in function or form, or a device made up of previously approved products, the manufacturer can file a PMN under Section k. A PMN must be filed at least 90 days before a device is due to enter the commercial market, documenting its substantial equivalence to a predicate device one which has already passed FDA investigation.
Compared to the lengthy, rigorous, and costly PMA process, a k notification is brief and much less expensive, largely due to the reduced requirements concerning clinical testing. Comparisons can be made when a new device has both the same intended use and the same underlying technology as a previously approved device, or it has the same intended use but different technology, as long as this technology does not provoke concern and is shown to be as effective and safe as the previously approved device.
If the new device is comparable in safety to the predicate device — thereby making further testing redundant — the FDA can grant clearance for the new device to be sold in the U. A database of previously approved medical devices is available on the FDA website and is searchable for manufacturers seeking a predicate device for comparison.
Documentation One of the greatest differences between the PMA and k processes is the amount and complexity of documentation required. Although documentation for both procedures is data-driven and subject to quality assurance, a k notification only requires documents verifying the functional similarity in terms of safety between the proposed medical device and an existing approved device.
This may require documentation of some testing but not the copious numbers of documents needed to file a PMA. Furthermore, there are several simplified k documents available, such as the Special k and the Abbreviated k. Each of these notification methods can substitute for the full-length k notification in certain circumstances. In contrast, a PMA involves detailed documentation of every stage of the clinical trials usually required for a Class III medical device.In light of this situation, over the last few years, the FDA has created a De Novo submission program, which allows for novel technologies i.
The De Novo submission process is similar in complexity to the k submission, but there are a number of differences:. If you need assistance making a determination regarding the submission requirements of your device or navigating the difference submission processes, please contact us link to contact section today via phone or email for a free consultation.
Medical Device Courses
Substantial equivalence requires the device is as safe and effective as the predicate device. Additionally, it requires the same intended use and technological characteristics as the predicate device. As such, the PMA submission process is quite rigorous, especially for a class II, medium risk device. The De Novo submission process is similar in complexity to the k submission, but there are a number of differences: Clinical Investigations — while clinical trials are sometimes not required for k submissions when based on previous clinical results for SE devicesclinical trials are required for virtually all De Novo submissions.
Risk Factor — For a De Novo submission, the manufacturer must prove that the risk factor presented with this device is a medium risk i.
As for k submission, the manufacturer must merely prove that the risk presented by the device is no greater than its SE device.Recent changes to the Food and Drug Administration Modernization Act of have facilitated the review and approval of novel devices.
The process of classification of the de novo mechanism is one such change. As such, device manufacturers should understand what a de novo classification is, the circumstances under which its use is appropriate, and scenarios under which device manufacturers can obtain a de novo classification. As part of the Food and Drug Administration Modernization Act ofthe de novo classification pathway functions as an alternative means of classifying low- to moderate-risk devices.
Traditionally, these devices were automatically classified as class III devices after the Food and Drug Administration determined that they are not substantially equivalent during review of a k application.
However, according to a amendment of section f 2 of the Federal Food, Drug, and Cosmetic Act, device manufacturers can apply for a de novo classification for a low- to moderate-risk device without submitting a k.
The Food and Drug Administration considers the de novo classification to be appropriate for devices that have not been classified under section a 1 of the Federal Food, Drug, and Cosmetic Act. These devices do not fit into any particular class, have no equivalent device that is currently marketed, or have not been determined to be substantially equivalent as the result of a k application. In addition, the device has to be low-to moderate-risk and meet all the requirements for classification as a class I or II device.
The device manufacturer should also be able to explain all the risks and benefits, how the risks can be decreased, and how efficacy can be ensured through appropriate checks and balances. There are two scenarios under which a device manufacturer can obtain a de novo classification. In both cases, the company must ask the Food and Drug Administration to evaluate whether the device is a class I or II device on the basis of its risks.
Under the first scenario, the device manufacturer submits a pre-submission to the Food and Drug Administration. The Food and Drug Administration then provides feedback on whether the de novo process is appropriate.
If the de novo mechanism is appropriate, the Food and Drug Administration provides information on the documentation necessary to submit a de novo application. Approval of a device via this scenario depends on whether the device manufacturer has conducted an effective search for an equivalent currently-marketed device, determined the risks and identified mechanisms to decrease such risks, and collected enough data for the Food and Drug Administration to determine its safety and efficacy.
Under the second scenario, a company can obtain a de novo classification by requesting it within thirty days after the Food and Drug Administration has determined that the device is not substantially equivalent. If there is no substantially equivalent device upon which to make a determination, the sponsor can ask the Food and Drug Administration to determine whether the mechanism is appropriate without submitting a k application.
For novel devices that would be considered low- to moderate-risk, and for which no substantially equivalent device is available, the de novo classification may be a viable option for companies who wish to market their devices without submitting a k application. Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution.What's even more interesting is that this regulatory pathway is slated for some major changes sometime in ; CDRH announced the changes as "major policy clarifications.
So why hasn't De Novo become a more commonly used pathway? This includes devices that do not fall within any existing classification regulation, where the De Novo requester either determines that there is no predicate device or has received an NSE determination on a k submission.
For devices that have already undergone k review, FDA will consider a De Novo request if the device has been determined to be NSE due to: 1 the lack of an identifiable predicate device, 2 a new intended use, or 3 different technological characteristics that raise different questions of safety and effectiveness. Devices that have been found to be NSE due solely to performance data that is inadequate to demonstrate substantial equivalence SE would generally be ineligible for the De Novo classification process.
In addition, the following criteria should be met for a device for which a De Novo request is submitted:. You should sufficiently understand and be able to explain all of the probable risks to health and probable benefits of the device, explain the measures needed to effectively mitigate all probable risks, and explain how device safety and effectiveness can be assured through the application of general controls or general and special controls.
Between De Novo and kin many ways, the De Novo pathway is the simpler option. Additional information provided by FDA on risk-benefit determinations.
In terms of safety and efficacy guidelines, the De Novo pathway is a little more demanding than k. When you take the k route, it is assumed that, as there is a predicate device on the market, then the device has already been deemed safe and effective. How do you decide if De Novo is the right pathway for your company? You must be able to demonstrate conclusively that your device should be classified as either Class I or Class II.
So make sure you are diligent throughout the process and the lines of communication are open with FDA throughout the review process. Be sure to not neglect the available resources and tools to help you during this process.
Medical device companies can benefit tremendously from utilizing the right quality system to manage this critical part of your pathway to market. The conventional approach to quality management systems in the medical device industry has always been through just a compliance lens, not quality. And that has made it very inefficient. See the Demo. Subscribe See the Demo. Search Results for:. What is the De Novo Pathway? Who qualifies for De Novo?
In addition, the following criteria should be met for a device for which a De Novo request is submitted: 1. Additional information provided by FDA on risk-benefit determinations In terms of safety and efficacy guidelines, the De Novo pathway is a little more demanding than k.
This is a useful way to obtain early feedback from the FDA.
Almost there! Please complete this form and click the button below to gain instant access. Related Articles. Approval vs. Read More.
Competitive Regulatory Strategy vs. Regular Regulatory Strategy. Want more free medical device resources? Get in-depth weekly articles, right in your inbox.
US FDA Medical Device Classification
Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality. Back to blog listing page.
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners.Several types of premarket submissions can be made to FDA. In order to legally market a device in the US, the most common forms of premarket submissions to FDA are the k premarket notification submission and the PMA premarket approval. Another lesser known premarket submission is the de novo submission. Each of these submission types result in a determination by FDA that clears [ k ], approves [PMA], or grants [de novo] marketing rights to the successful submitter.
The most commonly made submissions are described in more detail below. Each person who wants to market in the U. A k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective substantially equivalent to a legally marketed device that is not subject to PMA.
Submitters must compare their device to one or more similar legally marketed devices predicates and make and support their substantial equivalency claims. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.
Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the most stringent of the device marketing applications.
Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
PMA applications will include technical sections, usually divided into non-clinical laboratory studies and clinical investigations. PMA approval typically requires a facility inspection to confirm compliance to 21 CFR prior to approval. The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device. Upon successful review of a de novo submission, FDA creates a classification for the device, a regulation if necessary, and identifies any special controls required for future premarket submissions of substantially equivalent devices.
Pre-subs are used for various reasons including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol. The Pre-Sub Program can also provide a mechanism for the Agency to provide advice to sponsors who are developing protocols for clinical studies for which an IDE would not be required, such as studies of non-significant risk NSR devices or for clinical studies conducted outside of the U.
De Novo The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device.Post a Comment. Saturday, May 31, An Overview of the Difference ween a k and a de novo k. However, the risk involved with these de novo devices oftentimes has lower risk as in Class III devices. Therefore, a Class III classification with all its requirements is not warranted 1 and create unnecessary burden for sponsor. When a sponsors file for kit requires a demonstration of substantial equivalence to another legally US marketed device.
Substantial equivalence means that the new device is at least as safe and effective as the predicate device. It has the same intended use of the predicate device and the same technological characteristics as the predicate device 3. BUT it does not mean the new and predicate devices must be identical 3. How does a sponsor and the agency handle a product which is new and no predicate device?
It will be handled via de novo K. An overview of the differences between a K and a de novo K is tabulated in the table below. Overview of Differences. De novo K. Not Required. Swift, A. No comments:. Newer Post Older Post Home. Subscribe to: Post Comments Atom.
Technology 2. Substantial Equivalence 1,2. No substantial equivalent because it involves a new technology. Risk Factor 1,2. De novo sometimes has the risk profile of a traditional K. Generally, de novo process is for lower risk devices. Approval Mechanism 2. Prove of substantial equivalence. Not based on new technology, but based on risk the device presents. Submission of K 1. Then, sponsor can within 30 days to petition for de novo process to reclassify its device out of Class III.
Risk-Benefit Analysis 2. This is critical for the de novo petition. Device can then be classified into Class I or II. Human Experience like Clinical Investigations 2. Generally, not require. Must include any available data on clinical investigations.It can be confusing to know which submission type is the correct one for your particular development situation.
Like this episode? Additional Information:.
Are You Sure You Know The Best Regulatory Pathway For Your New Medical Device?
Beyond the basics, here are some additional resources to begin to appreciate the strategic advantages and challenges of the de novo:. There have been 40, k s. This is not the way the game is supposed to be played. Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.How Does the FDA Approve a Drug?
Jon Speer: De Novo, kgpre-submission, which submission makes the most sense? I know it's so confusing at times, and that's why I've got Mike Drues from Vascular Sciences joining me on this episode of The Global Medical Device Podcast, to try to make a little bit of sense of these various FDA submission types and when each of them might apply to your product development journey.
Frankly, you've heard him on our podcast so many times, offering all kinds of pearls of wisdom and I'm sure today will be just the same. Mike, welcome to the podcast. Mike Drues: Thank you, Jon, always a pleasure to be with you and your audience today. Jon Speer: Alright. Well, Mike, I wanna talk about a few things that have come up recently in various conversations, emails, things that I've been aware of here at greenlight.
It's all about regulatory today, and specifically we're gonna talk about some of the different FDA submissions, and the reason I wanna bring that up is because I think there is some real confusion about some of these different types of submissions. We're gonna talk a little bit about k s, De Novo, g s, pre-subs, and I was wondering first if maybe you can give a little bit of a perspective on when to submit a k versus a De Novo, where are they the same, where are they different.
Do you mind sharing a few thoughts about that? Mike Drues: Absolutely, Jon, it's a terrific question. I'm sure that the vast majority of your audience is very familiar with the kthat is after all the work horse of the medical device industry. But many of them probably are not familiar with, maybe they've at least heard of the De Novo, but I doubt too many have first hand experience with it because it is used not very frequently.
So let's do a quick compare and contrast between the two. Mike Drues: So first and foremost, both are pathways to market for medical devices here in the United States, for low to moderate risk medical devices. In other words, class one and class two devices.
The key difference is that the k as you well know, relies on the concept of substantial equivalents.
In other words, basically, at the end of the day, we have to show that our device is basically the same as, ie, substantial equivalent to another device, what we call a predicate device, that's already on the market here in the United States. And by the way, when we say basically the same as, what we mean is both in terms of labeling as well as technology. We have to show that the device is basically the same as the other device in terms of labeling and also technology.
We have to do both of those things. There is no requirement to show that a k device needs to be safe and effective, that requirement does not exist anywhere in the k regulation. In other words, you have to show that your device is basically the same as another that is already on the market. Since the other devices are already on the market, it is assumed to be safe and effective, therefore if your device do the same, it's assumed to be safe and effective.
Unfortunately, that doesn't always work, but that's the logic that it's based on. Mike Drues: On the De Novo side, there is no substantial equivalents. De novos are designed truly for new and novel, low and moderate risk devices.