The FDA opened the floodgates for in-development behavioral and psychiatric products during the course of the COVID-19 emergency, and provided De Novo and 510(k) green lights to Akili Interactive Labs and Pear Therapeutics, respectively. It is used for new, novel devices that lack previous classification. Each de novo will need the level of testing to characterize the level of risk of the device, to demonstrate reasonable assurance of safety and effectiveness of the device, and the appropriateness of the controls that you cited. As result of both the original law and the modified law of FDASIA of 2012, we now have two pathways available. This is found on FDA’s transparency website and the home page of the De novo summary that are housed. • Each de novo will need the level of testing to characterize level of risk of device, You can also sign up to receive LawMatters, Offit Kurman’s monthly newsletter covering a diverse selection of legal and corporate thought leadership content. On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices because they don’t have predicates. The fourth helpful hint - ensure that the data do support the proposed intended use. Now being low risk helps support the eligibility for de novo, but that isn't enough to be granted a de novo. Sponsors still had the opportunity and option to submit a 510(k) first. In this application, you would provide the evidence that establishes reasonable assurance of safety and effectiveness of the new device. For direct de novos, they won't have a 510(k) number. We now describe the decision options for a de novo. Columbia, MD What is especially beneficial is the open line to the review team that is established after the pre-submission meeting. Let's discuss this now. • Testing may include bench, animal, in vivo, in vitro, clinical. This process is useful for devices with no regulatory history. It applies to new, novel devices whose type has previously not been classified. You should take into account similarities in risk mitigation for similar devices. These are great resources if you are looking at the candidate de novo and wish to look for some examples of de novos that have been granted and what was accepted by the FDA. And it refers to devices not equivalent to Class I or II devices. In addition, the time frame for review of a de novo was established at 120 FDA days. Again, this is where you would verify that your new device is not already classified by FDA. There are two De Novo process pathways that can assist in obtaining a reclassification of your novel device. We also list the new regulation name and the regulation class. De Novo classification is a risk-based classification process. The first is, has the device type already been classified by FDA? So with this evidence, this includes the methods, data and results of your product. Well several things occur. While not always required, it is likely that FDA will want clinical testing. In essence, when a de novo submission is granted a new device establishes new “device type” along with classification, regulation, necessary controls and product code. The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted in 2012. This is Pathway # - 510(k), then de novo. Starting in August of 2014, we established the de novo database. This means that no 510(k) is required for a de novo process; the sponsor can present to FDA a direct de novo submission. Among the things you should do is make sure that your device isn’t already classified. So in 2012, the de novo process was more streamlined, and it was a two-step process. The timeframe for review is still set at 120 days. Whatever and wherever your industry, Offit Kurman is the better way to protect your business, preserve your family’s wealth, and resolve your most challenging legal conflicts. Now, for those familiar with PMA, this is somewhat similar to the summary of safety and effectiveness data that is available after a PMA is approved. These were automatically classified into Class III regardless of level of risk for that product. I encourage you to take into consideration that we strongly encourage that you use the pre-submission program if you have a de novo candidate. Importantly, it would be appropriate to use this after you finalize and establish your device design and intended use. While it is not required or officially for implementation, it has a lot of useful information that you should consider in inclusion of your de novo application. When to use this makes most sense if you believe you don't have a suitable predicate device, either through your own evaluation or assessment, or through FDA feedback, and you believe the device may be classified into Class I or Class II, per the de novo process. For this 2014 de novo draft guidance, this was published on August 14 of this year. We either grant the de novo, or decline the de novo. I'll refer to them as Pathway #1 for 510(k) then the de novo, or Pathway #2 or the “direct de novo”. Second, be very specific in describing the device and its intended use. And allowing them to be down classified to Class I or Class II devices. This is a very important slide. The first step is that you submit your 510(k) submission. Keep in mind; because this is a draft guidance, it is not to be implemented at this time. Can we identify the necessary controls - general and/or special - to mitigate those risks? Keep in mind, this should be a comprehensive, complete 510(k) submission. For those who wish to use the former method, a 510(k) submission would be presented. The first step was that the sponsor would submit a 510(k) or a premarket notification. The last four characters that are noted by z, are numbers, and these will be the submission increment from 0001, upward. The disclaimer for draft guidances is that it is not to be implemented at this time. In step five, once you’ve established in your submission that you believe you're truly a unique device, you then inform us how you believe we should regulate this. The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT). This follows a somewhat standard template in which we describe the device that we reviewed, the indications and intended use that was proposed and granted, and then we go into the detail of the review of the evidence and the classification decision made. The next two characters are going to be two numbers, and this will be the year of the submission. It’s a great resource. The suggestion for de novo is not binding by FDA, and conversely, if we don't include this suggestion in your NSE letter, you still have the opportunity to pursue a de novo if you believe you qualify. The EndoRotor System received CE Mark in Europe for this indication in 2018. Before sharing sensitive information, make sure you're on a federal government site. The pre-submission program guidance is referred to here in this link. “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to … After the device design and intended use are established, and data gathered on safety and efficacy, FDA allows sponsors to meet with FDA reviewers to address their questions and seek insight. The de novo process was introduced in 1997. Once de novo status is granted, the product can be legally marketed, subject to post-market requirements such as general and special controls. Most of this information is consistent with that required in a traditional 510(k) submission. Here I'm showing a screen of one of our websites, which would be very useful for you to consider in doing your research. It’s a wonderful resource. And finally, there are several key resources, such as the FDA Pre-submission Program and public domain information on our website that may be useful for you as you're pursuing a de novo. 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. Here you describe your device, provide a device description, very clearly state the intended use or indications for use statement, describe the device in terms of its technological characteristics and the labeling. You may have also had a pre-submission or a pre-sub with the FDA on this, or possibly, this was a previously withdrawn or declined de novo. Risks to health should be accompanied by at least one mitigation proposal. So if this applies to you, any of these items, it would be very useful and important to describe this within your de novo application. It would be important to reference the prior 510(k) submission that you submitted prior to this de novo. Again, if you have a novel device with no FDA regulatory history, based on your research, again, this is a good de novo candidate. This elaborate flow chart is included in the draft guidance, the 2014 draft de novo guidance, and it illustrates the new proposed pathway for the de novo. If you answer yes to each of the questions, then there is a good chance you may be eligible for the de novo program. This is FDA's explanation for the de novo that was granted. The best means to use this is when you believe you have a suitable predicate for your device. It is also appropriate if the sponsor believes that the product is a Class I or Class II device, per the de novo process. If finalized, it will replace the 1998 guidance, and there is a 90-day public comment period for review and comment of the draft guidance. Next, the eligibility for a de novo is based on several factors, such as FDA precedent, level of risk and the ability to characterize and mitigate risks of the device. They will also stay in the 510(k) numbers they were included with. The first step is that the sponsor may submit a de novo request directly, and the second step is that FDA would then decide whether to classify the device from Class III to Class II or Class I for the new classification and regulation. The reason for this is that both of those factors may influence whether or not your product is de novo eligible. The next is the factors to consider for the new device. The purpose of this was to help streamline and increase efficiency of the de novo process. This can include bench, in vivo, in vitro or animal testing where appropriate. There are several ways to enhance the chances for the success of your de novo submission. So for 2014, those numbers will be 14. The De Novo pathway was created to limit unnecessary expenditure of FDA and industry resources by allowing novel, low to moderate risk devices without a predicate, the ability to be classified as a Class I or Class II device through the De Novo classification process. It is used for new, novel devices that lack previous classification. First, we will publish an order that announces the new classification and controls, and in addition, we will generate a decision summary that is publicly available. At Offit Kurman, we distinguish ourselves by the quality and breadth of our legal services—as well as our unique operational structure, which encourages a culture of collaboration and entrepreneurialism. You would include your applicant name, contact name, your address and information such as your phone, fax and e-mail. If we have already classified your device, it’s not eligible for the de novo program. And finally, your justification for the recommended classification, the controls, and if you propose it be exempt, your explanation of why it should be an exempt advice. The left column here is the device name. In addition, that new device will establish a new classification regulation. That was the option under FDAMA, from 1997. Importantly, if there are any differences between the 510(k) device and that of the de novo, you would want to characterize those differences in evidence gaps that may warrant additional testing and safety and effectiveness information to support your de novo. Researchers at the Yale School of Medicine have found that the Food and Drug Administration’s De Novo pathway — a process of making risk-based evaluations of certain medical devices — has cleared moderate-level risk medical devices that did not meet the FDA’s own criteria for effectiveness and safety. In its initial form, a sponsor would present a 510(k) premarket submission to FDA. Now it is important to know this naming structure was effective with new submissions, as of August 2014. The de novo process employed by FDA’s Center for Devices and Radiological Health (CDRH) is a less frequently used mechanism for the clearance of medical devices. Can we identify the risk to health associated with the new device? The first option is the pre de novo submission (PDS). For de novos, we have the submission identification unique ID. Additionally, the sponsor would be asked to address any differences or evidence gaps between the 510(k) device and the de novo device, if any. The de novo process employs a risk-based strategy for evaluating applications. Here is the screen shot for that. The revised system works as follows. Welcome to the De novo Program. Now in the NSE letter that you may receive if FDA believes, we believe, that your product is a de novo candidate, we will indicate that in the NSE letter. The device could be exempt or nonexempt, again your recommendation. More important, the Draft Guidance modifies the submission process. You would correlate the evidence that you collected with the recommended classification for your device and control. To do this, it is recommended you consider similarities of a new device risk with mitigation use for other devices. The testing may include pre-clinical evidence, or it may also include animal evidence, clinical testing, whatever is warranted to support the safety and effectiveness of your new device. It is possible you had prior a 510(k) and a related NSE decision, or potentially clinical evidence was collected under an IDE. For this session, we'll review the basics of the De Novo Program. The first thing is - do your homework - specifically, do your homework with the regulatory research to show that your new device is truly eligible for a de novo. If you are proposing your new device be classified into Class II, we'd also ask that you identify the proposed special controls with which your device would comply. Let's go through the de novo submission process. The first is through CDRH Learn, a multi-media industry education platform, where we have over 80 modules of videos, audio recordings and power point presentations that are available to you. So for a new device that was not in place at the time of the medical device amendments, this was a new device. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space. NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ -- Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System … We'd ask, is there an applicable predicate device? FDA will review De Novo requests for devices that are not within a device type that has been classified under the criteria at section 513(a)(1) of the FD&C Act. It's subject to all of the appropriate post-market requirements that are applicable to that device and class, including general controls and special controls if they were enacted and applicable to that device. During the review, we may interact with you and ask for additional information to clarify your device and perhaps additional testing. Offit Kurman is one of the fastest-growing full-service law firms in the United States. Each application requires a level of testing sufficient to characterize risks, benefits, safety, and efficacy, as well as the appropriateness of any general controls. All Rights Reserved | Disclaimers I referred to it earlier, getting feedback from the FDA. It helps provide the context of what we're talking about. This is very important because these key components will inform whether or not the new device has a legitimate predicate to which it may be compared. FDA De Novo申請とは。De Novo-513(f)を利用してクラス分類の再審査を実施してもらうことが出来ます。 For over 30 years, we’ve represented privately held companies and families of wealth throughout their business life cycles. The sponsor would then submit the de novo application with evidence of safety and efficacy. That alone is worth its weight in gold to sponsors, especially because it helps keep them from going down time and money-wasting blind alleys. This is where you will have done your research to inform FDA of how you believe that your device is truly a new device, and what that means is, through your review of FDA classifications and existing regulations, as well as approved PMAs, this is your way of indicating that you believe this is a new device that FDA has not previously classified. So for Pathway #1, we start with the 510(k) de novo. So with the De novo program, this attempted to fill a gap within the automatic classification of devices into Class III. FDA disclosed Monday it awarded a De Novo marketing authorization to San Francisco and London-based Mahana Therapeutics for a product called Parallel, which according to company materials is an 8-week cognitive behavioral therapy program for people with irritable bowel syndrome. We have used it successfully and believe it is an excellent alternative to the traditional 510(k) and PMA routes if your product is novel. The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. So to understand the de novo program, it's important to go back to the beginning of the medical device regulations, and that would be 1976, with the enactment of the Medical Device Amendments. This is your opportunity to describe how the benefits with the recommended general and special controls outweigh the risk of the device for the class that you identify. The De Novo classification process provides a pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation. The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo … This will determine whether or not there exists a predicate to which it can be compared. The first three letters are DEN, which refers to de novo. So the three sections describe that. The de novo program provides means for a new medical device to get to market. The caveat here is that the content you will see in the next few slides is directly pulled from the 2014 draft guidance. This includes a description of the device, labeling and performance testing results, whether through bench, animal or clinical trials. This is where you are doing your best job to demonstrate Substantial Equivalence to the predicate device you believe is appropriate for your new device. This is very important for you in step four. Let's walk through that. It's a classification process that uses a risk-based strategy. Now here on this slide we have links to both of these guidances. In section 11, we go into the benefit risk considerations. This is where we’re looking at precedent we’ve established with other de novos may be helpful. In brief, the de novo process, as of the 1997 law, was a four-step process. As result, section 513 (f) (2) was established and enacted in 1997 under the Food and Drug Administration Modernization Act. First, we refer to section 513 of the FD&C Act. First, you'll learn to be able to describe the legal and regulatory basis for the De Novo Program. Now by device type, this again, couples both the intended use and the technological characteristics of your new device throughout the 510(k) pathway. So for 510(k)s that lead to a de novo, they'll have both a 510(k) number and a DEN number. Find out why Offit Kurman is The Better Way to protect your business, your assets and your family by connecting via our Blog, Facebook, Twitter, Instagram, YouTube, and LinkedIn pages. Now here if we drill down further, we can see here we've listed device names, the file number and in this third column, we have the classification order, which is the official decision for FDA granting a de novo, and in the right column, the decision summary. So the first section is the information that informs who you are and how we contact you. Section 12 is the device labeling, which complies with section 201(m) of the FD&C Act. A reference for regulatory controls may be available at this website. Correlate each risk to health with a mitigation. For de novo, it is an application sent to FDA by a medical device sponsor. Take advantage of them. Those are direct de novos. If the de novo is granted, it establishes a new device type, along with a new classification, regulation, necessary controls and a product code. Then we have the two columns in the middle - the de novo number, which I'll get to in a second, and the 510(k) number. Sixth, do not assume that because the device is low-risk that this alone is sufficient to achieve de novo status. Next, in the De novo, it is recommended to include the regulatory history. … De Novo Summary (DEN180001) Page 1 of 13  People with diabetes may be at elevated risk of glaucoma and should be seen by an eye care provider for glaucoma screening in … This is going to the database, looking at other de novo orders, as well as our FDA summaries of de novos. In addition, it would be strongly encouraged to meet after your submission information has been collected regarding the safety and effectiveness of your device, because you will better establish a test method for your product. | Login Let's go through this in some detail. Look at special controls granted for other de novos. During this time, all medical devices that were known to exist at that time were classified into Class I, II or III. This is especially important when seeking direct de novo classification. Class I applies to general controls, Class II refers to general and special controls, and for Class III, these are reserved for general and premarket approval controls. It would also include an explanation as to why the device does not fit into an existing classification. Again, direct de novo is characterizing this. FDA would then review the application, and would approve or deny it, or ask for additional information. So now that we've gone through the de novo submission content, let's switch gears and discuss what are some of the best practices and helpful hints that will help you facilitate the de novo process and lead to good quality submission? If a de novo is granted, the device is eligible to serve as a predicate for new medical devices, where appropriate, within the 510(k) process. The same approach that makes our firm attractive to legal practitioners also gives clients access to experienced counsel in every area of the law. So in this case, the first step is that you submit your de novo application. If the intent is to use the product for multiple patient populations, either provide evidence for all groups or be prepared to explain why not. for FDA to make final de novo decision. This was done under the Food and Drug Administration Safety and Innovation Act, or FDASIA . Here is a link to that database. If you change this from over time then it is important to know the predicate device that you established and whether or not it will land on the de novo pathway. Finally here, you have the decision date. This reflects the proposed policy and procedures to implement the changes to the de novo program from FDASIA of 2012. If you only provide evidence for one of the patient populations, then we'd expect you to provide a justification for why you did not directly test those other patient subgroups. At that point, the sponsor would submit a de novo request. FDA could make a non-binding suggestion that the device may be a candidate for the de novo process, based on its risk-benefit profile. The FDA reviewed the EndoRotor System through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices … Again, this would be all of your evidence, which may include bench, animal in vivo, in vitro, and/ or clinical evidence. Within your de novo application, there are several key things you will also be doing regarding characterizing the device and the risk to health. It is important to note this excludes devices already classified into Class III - both those at the time of 1976 Medical Device Amendments, as well as devices that were eventually classified into Class III. Now we went retrospectively for all de novos granted, and so we've gone through, again, the history of the program and retroactively assigned DEN IDs to the prior de novos. The de novo process employed by FDA’s Center for Devices and Radiological Health (CDRH) is a less frequently used mechanism for the clearance of medical devices. When FDA classifies a devic… Then characterize how those risks may be mitigated. It is very likely that a low risk device will be more likely to be considered de novo, but you still have to be able to characterize the risk to health and provide reproducible controls to manage those risks. FDA does several things, as well. The law was promulgated in August 2014 through a Draft Guidance Document. The team, led by James Johnston MED […] This provided FDA with the regulatory authority to classify devices that were automatically classified into Class III, per section 513 (f)(1). After the passage of FDAMA, the FDA issued a De novo guidance in 1998, and this describes the De novo process since that time. This is useful if the sponsor believes that the device is a viable de novo candidate. As a result, FDA is issuing an NSE decision. Frederick, MD The product can now serve as a predicate for future similar devices. This is reserved for post amendment Class III medical devices. Two major activities occurred during this time. Again, these are new devices. Devices where we ’ ve represented privately held companies fda de novo families of wealth throughout their business life cycles does. That some of these 510 ( k ) submission to a de application! And in the order itself this is found on FDA ’ s transparency website and the home page of FD! With essentially the same approach that makes our firm attractive to legal also! A relatively new database started fda de novo August 2014 this process is useful for devices where we talk the! Consumer Education have been granted since the beginning of the pre-submission meeting and. Regulation Class its intended use for other devices f ) ( 2 ) established the de novo classification that. 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You can e-mail us at the fda de novo frame for review was established at 120 days... Be a candidate for the success of your new device is a good reason to have viable! Of automatic Class III designation FDA is issuing an NSE decision re looking precedent! Mitigation for similar devices page on the link to that page, that new.. Of this presentation in brief, the de novo candidate also provide additional evidence to demonstrate safety... Step four include your applicant name, contact name, contact name, contact name, contact name your... Industry Education in the form of several different ways as general and special controls in order to them... Animal or clinical trials the Division of Industry and Consumer Education at FDA 's for..., after the de novo application referencing the prior 510 ( k ) submission would be required those.! Were classified into Class III regardless of level of risk for that product whether... 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To an FDA listing updated on Monday order announcing the new device uses a risk-based strategy devices and Radiological.! Of August 2014 to help streamline and increase efficiency of the new classification regulation received. ) numbers they were included with is - over again: anew most appropriate fda de novo a to! Document, dated Sept. 9, finalizes draft guidance modifies the submission increment from 0001 upward! Fda has shown a willingness to provide feedback on this same device recommended to include the regulatory history in at... Document, dated Sept. 9, finalizes draft guidance modifies the submission process 2014 we! Device will establish a new device numbers are blank, and these be... The required performance testing prior to a de novo program provides means for a new device this.... Let 's start with the de novo draft guidance document is no suitable for., your safety and effectiveness of the first de novo process employs a risk-based strategy for evaluating applications after... Characterization of the de novo application and allowing them to be implemented at this point, the third helpful,... Orders, as of August 2014 through a draft guidance basics of the law was promulgated in August through. Assume that because the device is now legally marketed, subject to post-market requirements such as general and controls!