A … FDA New Guidance on De Novo Classification Process … Correlate each risk to health with a mitigation. 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. Here is a sample of the first two pages of the FDA decision summary. This was done under the Food and Drug Administration Safety and Innovation Act, or FDASIA . The EndoRotor System received CE Mark in Europe for this indication in 2018. So as we recap, you’re probably thinking about this presentation and may be left with the overarching question - does my device qualify for de novo? This pertains to section 513 (f)(1). The caveat here is that the content you will see in the next few slides is directly pulled from the 2014 draft guidance. So to frame this conversation, let's start with the definition - what is a de novo? 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. So here is page one and three of a sample classification order, and as you can see, here we list new the regulation number. How to use de novo in a sentence. It’s a great resource. The team, led by James Johnston MED […] 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. 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 what changed was the ability to allow a sponsor to not submit a 510(k) prior to the de novo request. 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。 In section 11, we go into the benefit risk considerations. 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. 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. So let's recap. Once de novo status is granted, the product can be legally marketed, subject to post-market requirements such as general and special controls. This reflects the proposed policy and procedures to implement the changes to the de novo program from FDASIA of 2012. The newer process is most appropriate when a sponsor believes that there is no suitable predicate, or when FDA recommends the newer pathway. 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. 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. We have several resources that describe these processes. 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. So first, the new device is now legally marketed. Well several things occur. De novo definition is - over again : anew. This is especially important when seeking direct de novo classification. Again, if you have a novel device with no FDA regulatory history, based on your research, again, this is a good de novo candidate. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The pre-submission program guidance is referred to here in this link. Keep in mind; because this is a draft guidance, it is not to be implemented at this time. In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513 (f) (2) of … It is used for new, novel devices that lack previous classification. I have links for both of these resources on the slide. Here is the screen shot for that. The timeframe for review is still set at 120 days. Importantly, the intent and decision making threshold for de novo was unchanged. Offit Kurman is one of the fastest-growing full-service law firms in the United States. 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. This process is useful for devices with no regulatory history. Again, these are new devices. As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an FDA has shown a willingness to provide feedback on this question. At this point, the sponsor would present the de novo submission. By lack of a predicate, what we mean is that the proposed predicate device that you proposed does not have the same intended use and technological characteristics as your new device. The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted in 2012. 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. In 2012, we made further modifications to the De novo Program. Does the device present low risk or moderate risk? 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? 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. This is a very important slide. Sponsors still had the opportunity and option to submit a 510(k) first. For de novo, it is an application sent to FDA by a medical device sponsor. You should take into account similarities in risk mitigation for similar devices. Now it’s important to note that clinical evidence may not always be required for a de novo submission, but it’s likely in many cases. Can we identify the risk to health associated with the new device? 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. 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. • Testing may include bench, animal, in vivo, in vitro, clinical. When FDA classifies a devic… While not always required, it is likely that FDA will want clinical testing. 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. This provided FDA with the regulatory authority to classify devices that were automatically classified into Class III, per section 513 (f)(1). Well, this guidance explains the changes to FDASIA and the FD&C Act. At that point, the sponsor would submit a de novo request. In the event a Class II designation is proposed, a proposal for special controls for mitigating risk would be required. It is used for new, novel devices that lack previous classification. 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. On the bottom left, we also have a description of the new device. Thanks for watching. They will also stay in the 510(k) numbers they were included with. Sixth, do not assume that because the device is low-risk that this alone is sufficient to achieve de novo status. Specifically, to allow the alternate pathway that does not require the submission of a 510(k) prior to the de novo request. 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. 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. | Login The third helpful hint - complete all the required performance testing prior to submission of the de novo. The FDA reviewed the EndoRotor System through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices … Through the PMA pathway, we would ask, has the device type been approved under a PMA? Within your de novo application, there are several key things you will also be doing regarding characterizing the device and the risk to health. Plymouth Meeting, PA, Baltimore, MD And here we listed all the de novos that have been granted since the beginning of the program in 1997. The first step is that you submit your 510(k) submission. The FDA has granted De Novo clearance to a prescription treatment for irritable bowel syndrome (IBS) from Mahana Therapeutics.. San Francisco-based … During this time, all medical devices that were known to exist at that time were classified into Class I, II or III. 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. Ultimately, we’ll render a final de novo decision. This is a relatively new database started in August. This is very important for you in step four. 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. DELAWARE | MARYLAND | NEW JERSEY | NEW YORK | NORTH CAROLINA | PENNSYLVANIA | VIRGINIA | WASHINGTON, DC, New York City (Manhattan), NY The device could be exempt or nonexempt, again your recommendation. 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. Now in this case, FDA will make the NSE decision, Not Substantially Equivalent decision, due to lack of  a predicate. Contact us to discuss ways in which we can help you get your device approved. The de novo process employs a risk-based strategy for evaluating applications. So what are the major items of the draft guidance of 2014? It should include a characterization of any risks to health associated with the use of the new device, as well as a mitigation plan. 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. Bethesda, MD, ©2020 Offit Kurman, Attorneys At Law. You have a new device, you believe you have a viable predicate, so this is the option to consider using. This can include bench, in vivo, in vitro or animal testing where appropriate. The revised system works as follows. As result, section 513 (f) (2) was established and enacted in 1997 under the Food and Drug Administration Modernization Act. Once you received an NSE, you then may follow up with the de novo application. Before sharing sensitive information, make sure you're on a federal government site. The same approach that makes our firm attractive to legal practitioners also gives clients access to experienced counsel in every area of the law. It helps provide the context of what we're talking about. The agency made its decision on November 25, according to an FDA listing updated on Monday. The de novo process employs a risk-based strategy for evaluating applications. It may also conclude that an existing predicate device does not have the same intended use and technological characteristics as the new device. Most of this information is consistent with that required in a traditional 510(k) submission. 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. We'd ask, is there an applicable predicate device? We either grant the de novo, or decline the de novo. Your de novo application should be your best effort to include all of the comprehensive and necessary information for FDA to make the final de novo decision. 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. So for a de novo that is not preceded by 510(k), we refer to this as the “direct de novo”. And allowing them to be down classified to Class I or Class II devices. Now this slide talks about the actual spirit of the classification and characterization of the risk and mitigation of these risks. One way to do this is by reviewing the special controls assigned to other approved de novo devices. Then characterize how those risks may be mitigated. 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. 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. So in this case, the first step is that you submit your de novo application. Here I'm showing a screen of one of our websites, which would be very useful for you to consider in doing your research. We also have Device Advice, a text-based educational resource with a wide range of pages that provide comprehensive regulatory information on pre-market and post-market topics. 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. 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. Fifth, each risk must be correlated to health with a mitigation plan. 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. This is also known as the evaluation of Automatic Class III designation. Two major activities occurred during this time. Section 513 (f)(2) established the de novo classification process. 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. 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. Now you have another option, Pathway #2, the direct de novo. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 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. For this session, we'll review the basics of the De Novo Program. FDA would then review the application, and would approve or deny it, or ask for additional information. Again, this would be all of your evidence, which may include bench, animal in vivo, in vitro, and/ or clinical evidence. This is a comprehensive listing of all de novos that have been granted since the beginning of the program. Among the things you should do is make sure that your device isn’t already classified. It’s for devices that would otherwise be classified into Class III, and provides a means to classify into Class I or II. FDA would decide whether to classify the product as a Class I or II device. This is found on FDA’s transparency website and the home page of the De novo summary that are housed. 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. So you provide a recommended classification, either Class I or Class II. This is Pathway # - 510(k), then de novo. In addition, the time frame for review of a de novo was established at 120 FDA days. The sponsor would then submit the de novo application, with essentially the same information as that required in the first de novo pathway. These would ordinarily be Class III devices, but under de novo classification could be Class I or Class II devices. As result of both the original law and the modified law of FDASIA of 2012, we now have two pathways available. Those are direct de novos. As I showed in that prior slide, there were some de novos that had only the DEN number and no 510(k). More important, the Draft Guidance modifies the submission process. Fourth, ensure that the data support your intended use. The left column here is the device name. So in 2012, the de novo process was more streamlined, and it was a two-step process. You would include your applicant name, contact name, your address and information such as your phone, fax and e-mail. We also list the new regulation name and the regulation class. 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. Frederick, MD During the course of this presentation, we'll cover several learning objectives. The disclaimer for draft guidances is that it is not to be implemented at this time. Again, this is a very important section, so if your device was approved under a PMA or previously cleared under a 510(k), you're not eligible for the de novo. 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. In brief, the de novo process, as of the 1997 law, was a four-step process. In this application, you would provide the evidence that establishes reasonable assurance of safety and effectiveness of the new device. Again, the time frame for review was established for 120 FDA days. For Class III, again, these are devices that require premarket approval, and these were reserved for devices at the highest level of risk. Now here on this slide we have links to both of these guidances. It would present any additional evidence to demonstrate the safety and effectiveness of the new device. 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 … It provided FDA with the ability to classify Class I or II using the criteria of section 513 (a)(1), A& B. The time frame for review was set at 120 days. For de novo, it is an application sent to FDA by a medical device sponsor. If we have already classified your device, it’s not eligible for the de novo program. Let's walk through that. 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. It would also include an explanation as to why the device does not fit into an existing classification. FDA would then decide whether or not a predicate device exists. With 14 offices in seven states, and the District of Columbia, and growing by 50% in two years through expansions in New York City and Charlotte, North Carolina, Offit Kurman is well-positioned to meet the legal needs of dynamic businesses and the individuals who own and operate them. Dive Brief: FDA issued final guidance to explain its procedures and criteria, including the types of information needed, for assessing whether a device manufacturer’s De Novo classification request should be accepted for substantive review. What is important to note, is that due to the enactment of FDASIA of 2012, some acts of this guidance may no longer be current. The guidance describes and goes into some detail of the pre-submission meeting process and we introduce a new term. Can we identify the necessary controls - general and/or special - to mitigate those risks? for FDA to make final de novo decision. Philadelphia (Center City), PA This will typically include information submitted in the traditional 510(k) submission, such as the device description, the labeling, and performance testing, which may be bench, animal and/or clinical evidence, and then you go through the classification information in which you would characterize the risk to health associated with the new device, characterize how risk may be mitigated, providing the rationale for why the device does not fit into an existing regulation, either 510(k) or PMA, and again, if you propose a Class II classification, then identifying special controls to mitigate the risk to health. 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. These are all great resources for you to consider. The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo … The first option is the pre de novo submission (PDS). Again, this is where you would verify that your new device is not already classified by FDA. Again, this is going back to section 513 (f)(1) of the FD&C Act. The first step was that the sponsor would submit a 510(k) or a premarket notification. In addition, that new device will establish a new classification regulation. This is useful if the sponsor believes that the device is a viable de novo candidate. Next, provide a rationale for why the device does not fit into any existing regulation, and if you propose Class II classification, you’d also describe the special controls to mitigate the risk to health. 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. Next, we’ll review and describe the de novo submission process. You would correlate the evidence that you collected with the recommended classification for your device and control. Note that some of these 510(k) numbers are blank, and I will explain that in a second. We now describe the decision options for a de novo. This is based on the risk-benefit profile, not the adequacy of the evidence or data that you submitted in your 510(k). For this 2014 de novo draft guidance, this was published on August 14 of this year. During the review, we may interact with you and ask for additional information to clarify your device and perhaps additional testing. Now by device type, this again, couples both the intended use and the technological characteristics of your new device throughout the 510(k) pathway. For those who wish to use the former method, a 510(k) submission would be presented. A welcome feature of the revised de novo process is the pre-submission program. A new pathway called direct de novo has been added. 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. And finally, the third and perhaps the most significant, is our division itself, the Division of Industry and Consumer Education. 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. This is going to the database, looking at other de novo orders, as well as our FDA summaries of de novos. Suggestion that the data do support the proposed intended use and technological characteristics as the evaluation of automatic Class medical. Whether or not a predicate however, the sponsor would present a 510 ( ). Been granted since the beginning of the classification summary contact us by phone be two numbers, this! For post amendment Class III regardless of level of risk for that product here to the novo... 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