Note that some of these 510(k) numbers are blank, and I will explain that in a second. Contact us to discuss ways in which we can help you get your device approved. Again, this is going back to section 513 (f)(1) of the FD&C Act. 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. Each application requires a level of testing sufficient to characterize risks, benefits, safety, and efficacy, as well as the appropriateness of any general controls. 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 first three letters are DEN, which refers to de novo. 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). FDA would then review the application, and would approve or deny it, or ask for additional information. Now by device type, this again, couples both the intended use and the technological characteristics of your new device throughout the 510(k) pathway. The FDA reviewed the EndoRotor System through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices … for FDA to make final de novo decision. Bethesda, MD, ©2020 Offit Kurman, Attorneys At Law. 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. Now this slide talks about the actual spirit of the classification and characterization of the risk and mitigation of these risks. De Novo: De novo provides a possible route to classify novel devices of low to moderate risk. 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. During this time, all medical devices that were known to exist at that time were classified into Class I, II or III. 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. Specifically, to allow the alternate pathway that does not require the submission of a 510(k) prior to the de novo request. We either grant the de novo, or decline the de novo. Sixth, do not assume that because the device is low-risk that this alone is sufficient to achieve de novo status. It would present any additional evidence to demonstrate the safety and effectiveness of the new device. If you have a question, you can e-mail us at the address listed on the slide or contact us by phone. The reason for this is that both of those factors may influence whether or not your product is de novo eligible. So for a de novo that is not preceded by 510(k), we refer to this as the “direct de novo”. 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 would decide whether to classify the product as a Class I or II device. Then characterize how those risks may be mitigated. 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. For over 30 years, we’ve represented privately held companies and families of wealth throughout their business life cycles. At this point, the sponsor would present the de novo submission. A new pathway called direct de novo has been added. Now in this case, FDA will make the NSE decision, Not Substantially Equivalent decision, due to lack of  a predicate. FDA would then issue a final 510(k) decision that the product was not substantially equivalent because it had no predicate. Importantly, it would be appropriate to use this after you finalize and establish your device design and intended use. For de novos, we have the submission identification unique ID. De Novo classification is a risk-based classification process. Well several things occur. In this application, you would provide the evidence that establishes reasonable assurance of safety and effectiveness of the new device. Can we identify the necessary controls - general and/or special - to mitigate those risks? Now it is important to know this naming structure was effective with new submissions, as of August 2014. The sponsor would then submit the de novo application with evidence of safety and efficacy. In brief, the de novo process, as of the 1997 law, was a four-step process. That new device is then eligible to serve as a predicate for future similar devices, which would then follow the standard 510(k) process. Once de novo status is granted, the product can be legally marketed, subject to post-market requirements such as general and special controls. It would also include an explanation as to why the device does not fit into an existing classification. Second, be very specific in describing the device and its intended use. The first step is that you submit your 510(k) submission. 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. The same approach that makes our firm attractive to legal practitioners also gives clients access to experienced counsel in every area of the law. 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. As result, section 513 (f) (2) was established and enacted in 1997 under the Food and Drug Administration Modernization Act. At that point, the sponsor would submit a de novo request. In 2012, we made further modifications to the De novo Program. It’s for devices that would otherwise be classified into Class III, and provides a means to classify into Class I or II. The newer process is most appropriate when a sponsor believes that there is no suitable predicate, or when FDA recommends the newer pathway. However, the information, especially for this information, may be useful for consideration and inclusion in your submission. 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. In its initial form, a sponsor would present a 510(k) premarket submission to FDA. Here I'm showing a screen of one of our websites, which would be very useful for you to consider in doing your research. As I showed in that prior slide, there were some de novos that had only the DEN number and no 510(k). It is used for new, novel devices that lack previous classification. How to use de novo in a sentence. So you provide a recommended classification, either Class I or Class II. FDA will publish an order announcing the new classification and the appropriate controls, as well as a decision summary that is publicly available. For de novo, it is an application sent to FDA by a medical device sponsor. And allowing them to be down classified to Class I or Class II devices. It should include a characterization of any risks to health associated with the use of the new device, as well as a mitigation plan. Research everything and all available databases, including 510(k), PMA and classification databases, as well as the de novo database in order to fully understand FDA’s prior decisions on devices we’ve classified. Risks to health should be accompanied by at least one mitigation proposal. 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 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 sponsor would then submit the de novo application, with essentially the same information as that required in the first de novo pathway. The disclaimer for draft guidances is that it is not to be implemented at this time. Finally, FDA will then review the de novo application. Now being low risk helps support the eligibility for de novo, but that isn't enough to be granted a de novo. Two major activities occurred during this time. The fourth helpful hint - ensure that the data do support the proposed intended use. 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. Through the PMA pathway, we would ask, has the device type been approved under a PMA? Next, FDA would issue a final 510(k) decision of Non-Substantial Equivalent due to no predicate. This was done under the Food and Drug Administration Safety and Innovation Act, or FDASIA . We now describe the decision options for a de novo. 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 … In the event a Class II designation is proposed, a proposal for special controls for mitigating risk would be required. De novo definition is - over again : anew. NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ -- InterScope Technologies, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System in the United States for direct endoscopic necrosectomy (DEN), a minimally invasive treatment for walled-off pancreatic necrosis. So what didn't change was that de novo only applied to devices that were considered new devices, that is, those devices that would be classified under section 513 f1 of the FD&C Act. It calls for, among other things, a pre-submission meeting, which will be discussed later in this article. First, you'll learn to be able to describe the legal and regulatory basis for the De Novo Program. The device is then eligible to serve as a predicate for new medical devices, where appropriate. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. On page three, we have the discussion regarding the risk and how risks were mitigated. Again, this is where you would verify that your new device is not already classified by FDA. So with the De novo program, this attempted to fill a gap within the automatic classification of devices into Class III. 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. So the three sections describe that. The last four characters that are noted by z, are numbers, and these will be the submission increment from 0001, upward. This pertains to section 513 (f)(1). As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an Again, these are new devices. It may also conclude that an existing predicate device does not have the same intended use and technological characteristics as the new device. 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 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. Third, the information needed in a de novo includes evidence that both demonstrate the safety and effectiveness of a new device, as well as the ability to classify the device and the device type. NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ -- Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System in the United States for direct endoscopic necrosectomy (DEN), a minimally invasive treatment for walled-off pancreatic necrosis. This pathway is intended to limit unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to a PMA due to a lack of a predicate. More recently, after the passage of FDASIA, we issued the 2014 de novo guidance in draft. FDA does several things, as well. This provided FDA with the regulatory authority to classify devices that were automatically classified into Class III, per section 513 (f)(1). Next, this is where we talk about the classification summary. 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 Section seven, this is where you would provide your evidence, your safety and effectiveness evidence that supports your product. The FDA provides industry education in the form of several different ways. 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 pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device. It … Offit Kurman is one of the fastest-growing full-service law firms in the United States. This is FDA's explanation for the de novo that was granted. The De Novo process was added to the statute in 1997 under the Food and Drug Administration Modernization Act (FDAMA) and has been modified as part of the FDA … 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. A welcome feature of the revised de novo process is the pre-submission program. This process is useful for devices with no regulatory history. Let's go through the de novo submission process. All Rights Reserved | Disclaimers The .gov means it’s official.Federal government websites often end in .gov or .mil. … 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. Now you have another option, Pathway #2, the direct de novo. The de novo process employs a risk-based strategy for evaluating applications. A reference for regulatory controls may be available at this website. 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. 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. The document, dated Sept. 9, finalizes draft guidance issued on Oct. 30, 2017. In addition, the time frame for review of a de novo was established at 120 FDA days. First among these is to do your homework before applying in order to ensure that your device is in fact eligible for de novo classification. The de novo pathway where applicable is an excellent way to get your device to market. 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. The time frame for review was set at 120 days. So for Pathway #1, we start with the 510(k) de novo. 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. Here is the screen shot for that. This is very important step and a helpful hint if you pursue direct de novo, and especially if you don't obtain FDA feedback prior to doing so. Here is the example. The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted in 2012. 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. Again, this would be all of your evidence, which may include bench, animal in vivo, in vitro, and/ or clinical evidence. Can we identify the risk to health associated with the new device? So with this evidence, this includes the methods, data and results of your product. It is possible you had prior a 510(k) and a related NSE decision, or potentially clinical evidence was collected under an IDE. The law was promulgated in August 2014 through a Draft Guidance Document. Let's walk through that. The next step is that FDA reviews your 510(k) submission. Before sharing sensitive information, make sure you're on a federal government site. More important, the Draft Guidance modifies the submission process. Next, we get into the device itself. 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