I. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. The EndoRotor System should not be used in patients with walled-off necrosis who have a documented pseudoaneurysm (when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue) greater than 1 cm within the cavity or with intervening gastric varices (swollen veins in stomach) or unavoidable blood vessels within the access tract; or in patients with known or suspected pancreatic cancer. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request. To aid in the acceptance review, we recommend requesters complete and submit Acceptance Checklists (see the guidance document) with their De Novo requests that identify the location of supporting information for each checklist element. If you have questions on whether your product is a combination product, ... FDA received your De Novo requesting classification of the t:Slim X2 insulin pump with interoperable technology. During the substantive review of a De Novo request, the Lead Reviewer may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information (Additional Information letter). Two of these subjects experienced gastrointestinal bleeding. Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. Subjects often required multiple procedures, for a total of 63 direct endoscopic necrosectomies with the EndoRotor System to remove necrotic debris from the pancreatic cavity. For further information on the review process, please reference the following guidance documents: The FDA may either grant or decline a De Novo request. Fixed combination medicinal products offer the possibility to simplify administration where a combination of active substance s is already recognised with an existing therapeutic claim . Additional information about medical device user fees and the small business qualification program can be found on the Medical Device User Fees and Reduced Medical Device User Fees: Small Business Determination (SBD) Program webpages. Study subjects were treated using the EndoRotor System during the procedure. According to the company, since the introduction of the device in Europe in 2012, BONEBRIDGE remains the first and only active bone conduction … The site is secure. The FDA granted marketing authorization of the EndoRotor System to Interscope, Incorporated. The device represents breakthrough technologies that have no cleared or approved alternatives already available on the US market; offer significant advantages over existing alternative devices; and for which availability is in patients’ best interest. FDA granted de novo for the EndoRotor System to resection (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis. 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 requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.Note: The response must be received by the Document Control Center (DCC) within 180 calendar days of the date of the Additional Information letter. The Food and Drug Administration considers the de novo classification to be appropriate for devices that have not been classified under section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act. FDA reviewers will classify De Novo submissions according to US law and via written order within 120 days of receiving submissions. Section 3038 of the 21st Century Cures Act, enacted in December 2016 (P.L. The proposed regulations, if finalized, are intended to provide structure, clarity and transparency on the De Novo classification process, including requirements related to the format and content of De Novo requests, as well as processes and criteria for accepting, granting, declining and withdrawing De Novo requests. Devices that are classified into class I or class II through a De Novo Classification Request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, if necessary. What is a De Novo Classification Request? This panel will discuss FDA’s streamlining of the de novo process and the recently proposed de novo regulation, which, when finalized, will codify the pathway in existence since 1997. Alternatively, a fixed combination medicinal product may be developed de novo to address a new therapeutic claim. Learn what a de novo request is and when it will be For information on acceptance of clinical data, refer to FDA's guidance document entitled  ", Non-clinical data including bench performance testing. 2. 1. If any of the acceptance elements are not included, there should be a justification for the omission. The current mailing address for CDRH's Document Control Center and a link to the Center for Biologics Evaluation and Research's (CBER) Document Control Center's mailing address are provided on the eCopy Program for Medical Device Submissions webpage. Background IV. The FDA generates and publicly discloses a decision summary. Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) submission to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in part .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). 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). On December 7, 2018, the FDA published a proposed rule to establish regulations for the De Novo classification process. However, during the RTA review, the FDA staff has discretion to determine whether missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted. the De Novo request has been accepted for substantive review; the De Novo request has not been accepted for review (i.e., considered refused to accept or RTA) and the requester has 180 calendar days to fully address the RTA notification. NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ -- Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System … The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020. The De Novo number begins with "DEN" followed by six digits. NORTHBRIDGE, Mass., Dec. 24, 2020 /PRNewswire/ -- Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System … Define substantial equivalence and predicate devices. The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. The .gov means it’s official.Federal government websites often end in .gov or .mil. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device. The EndoRotor System should only be used in patients following other procedures to drain the walled-off pancreatic necrosis. The amount of necrotic tissue in each subject’s pancreas was measured during a computerized tomography scan with contrast before the procedure and compared to a follow up CT scan, endoscopy or MRI 14 to 28 days after the last procedure. The agency made its decision on November 25, according to an FDA listing updated on Monday. Second, the user places the EndoRotor through the working channel of the endoscope to cut and remove the necrotized tissue. And allowing them to be down classified to Class I or Class II devices. Necrotizing pancreatitis occurs when part of the pancreas dies because of inflammation or injury. An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests Examine the legal basis and content for a 510(k). If your data and information demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and the probable benefits of the device outweigh the probable risks, then the FDA intends to grant the De Novo request and establish a new classification regulation for a new device type. In order to reconcile these new device types with the classification regulations and the 510(k) program, sponsors are increasingly pursuing the de novo process. Before sharing sensitive information, make sure you're on a federal government site. Applicants may submit De Novo requests without first utilizing the 510(k) submission route if they determine there are no suitable predicate devices for their products on the US market. We recommend submitting a De Novo request to the FDA by a method that will provide a signed receipt of delivery, for example, registered mail with a return receipt or a commercial delivery service. Pancreatitis occurs when digestive enzymes and inflammation cause cellular damage or tissue death. A De Novo request should include all the content elements necessary for acceptance of the De Novo request, listed in Appendix A of the "Acceptance Review for De Novo Classification Request" guidance document. “One thing it is important for m… Learn more about FDA … After several weeks, the area of necrosis may form a walled off cavity and become what is called walled-off pancreatic necrosis. The FDA is requiring a boxed warning to emphasize this important point. If you have questions on whether your product is a combination product, ... FDA received your De Novo requesting classification of the t:Slim X2 insulin pump with interoperable technology. Another lesser known premarket submission is the de novo submission. There are two options for when a requester can submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into class I or II. The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions. Option 1: After receiving a high-level not substantially equivalent (NSE) determination (that is, no predicate, new intended use or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Prior to submitting a De Novo request to the FDA, we recommend you consider submitting a pre-submission to obtain feedback from the appropriate premarket review division. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. The EndoRotor System should not be used in patients with known or suspected pancreatic cancer per the assessment of the treating physician. Learn how to strategize for a 510(k) submission. For the current user fee amounts, please see MDUFA User Fees. Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert,” by David Lim. Under MDUFA IV, the FDA's goal is to make a decision about a De Novo request in 150 review days. For subjects undergoing procedures with the EndoRotor System, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having 98.5% clearance of their necrotic tissue. Administrative Information, such as the device's intended use, prescription use or over-the-counter use designated, etc. FDA granted de novo for the EndoRotor System to resection (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis. What are the De Novo Request MDUFA User Fees? The De Novo decision summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the FDA's decision to grant a De Novo request. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. MedTech Dive January 8, 2019. Executive Summary A. Classification Information and Supporting Data: The classification being recommended under section 513 of the Food, Drug, and Cosmetic Act (FD&C Act). The De Novo decision summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the FDA's decision to grant a De Novo request. Several types of premarket submissions can be made to FDA. The EndoRotor System includes a power console, foot control, specimen trap and single-use catheter, and is used in a procedure called direct endoscopic necrosectomy that broadly consists of two steps. the De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days. 1-888-INFO-FDA (1-888-463-6332) Contact FDA The FDA is aware of a patient death (outside of the U.S.) from pancreatic cancer three months after having necrotic pancreatic tissue removed with the EndoRotor System. Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul. This averaged 2.1 procedures per subject. De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Acceptance Review for De Novo Classification Request, Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, De Novo Classification Process (Evaluation of Automatic Class III Designation), Acceptance Review for De Novo Classification Requests, eCopy Program for Medical Device Submissions webpage, Reduced Medical Device User Fees: Small Business Determination (SBD) Program, Acceptance Checklists (see the guidance document), FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Guidance for Industry and Food and Drug Administration Staff, Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff, Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, Evaluation of Automatic Class III Designation (De Novo) Summaries, User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff, Webinar - Acceptance Review for De Novo Classification Requests, Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and FDA Staff. For example, the first De Novo request received in the calendar year 2017 would be DEN170001. 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 FDA reviewed the EndoRotor System through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence. De Novo classification is a risk-based classification process. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the Additional Information letter, the request will be considered withdrawn and deleted from the FDA's review system. The first two digits represent the calendar year in which the request was received, and the last four digits represent the sequential request number for that year. A De Novo marketing authorization establishes a new classification category for low- to moderate-risk, first-of-a-kind products. First, the user creates a portal, typically using a metallic stent, between the stomach and the necrotic cavity in the pancreas. For information on assessing the benefits and risks of your device, refer to FDA's guidance entitled ". A … FDA New Guidance on De Novo Classification Process … With today’s marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option.”. If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. Beginning in 2010, the FDA has published decision summary documents for devices classified through the De Novo process. The .gov means it’s official.Federal government websites often end in .gov or .mil. The FDA will issue a written order to the requestor identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the Document Control Center (DCC) of the appropriate Center. Guidance on process for submission and review of a De Novo classification request. In order to legally market a device in the US, the most common forms of premarket submissions to FDA are the 510(k) premarket notification submission and the PMA premarket approval. When CDRH or CBER receives a De Novo request, the appropriate Center assigns the request a unique document number. After a comment period, it may be re‑issued as a final rule to take affect 90 days after publication. 1-888-INFO-FDA (1-888-463-6332) Contact FDA FDAnews Combination Products Conference, June 8, 2017. The FDA reviewed the BEAR Implant through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Please refer to docket FDA-2018-N-0236 for the proposed rule and comments received. 510(k), De Novo, or PMA Combination Product with a Drug/Biologic Constituent Part. In the clinical trial, three subjects experienced procedure-related serious adverse events (a 10% complication rate). instead be combination products. The request was submitted under section 513(f)(2) of the FD&C Act. This patient did not have a diagnosis of pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure. The requester generally should either submit an application for premarket approval under section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information. For further information, please reference the guidance documents: De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff and Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. As part of FDA’s preliminary analysis, the final guidance instructs the reviewer to determine whether a De Novo request for a combination product contains as a constituent a drug that has the same active moiety as an approved drug with exclusivity, as described in section 503(g)(5)(C)(ii)-(v). 510(k), De Novo, or PMA Combination Product with a Drug/Biologic Constituent Part. “Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. Scope (Proposed Subpart D and § 860.1) B. Definitions (Proposed § 860.3) C. Confidentiality of Information and Data Related to a De Novo Request (Proposed § 860.5) D. De Novo Classification—Gen… The new device is authorized to be marketed and must be in compliance with applicable. Discuss FDA’s 510(k) review process. Option 2: Upon the requester's determination that there is no legally marketed device upon which to base a determination of substantial equivalence (therefore without first submitting a 510(k) and receiving a high-level NSE determination). General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or, The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or. The FDA assessed the safety and effectiveness of the EndoRotor System in a trial with 30 subjects (23 enrolled in the U.S.) with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy. No extensions beyond 180 days will be granted. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. For assistance with De Novo requests submitted to the Center for Biologics Evaluation and Research (CBER), please contact 1-800-835-4709 or Industry.Biologics@fda.hhs.gov. This is why the FDA has the "de novo" process. 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. Moderator: Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP. Requests should be sent to the appropriate Document Control Center (DCC). One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. You may consider filing a de novo submission if the FDA determines, through means such as a 513(g) or Pre-Submission, that your device is a “novel” with no existing classification or predicate device on the market. In order to qualify for participation in the Breakthrough Devices Program, a device must meet two key criteria: 1. After the classification review is complete, the FDA will begin the substantive review of the De Novo request. The FDA intends to Refuse to Accept a De Novo request that does not include these elements. Learn more about FDA … This information is publicly available in the De Novo Classification Requests database and also published on the CDRH Transparency website Evaluation of Automatic Class III Designation (De Novo) Summaries. If an Additional Information letter is sent, then the De Novo request will be placed on hold. Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions. Before sharing sensitive information, make sure you're on a federal government site. De Novo requests should include: A new classification regulation is established; The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type; The FDA posts on its website a copy of the granting order notifying the requester we have granted marketing authorization; and. For further information on the De Novo request content, please reference the guidance documents "De Novo Classification Process (Evaluation of Automatic Class III Designation)"  and "Acceptance Review for De Novo Classification Requests.". Within 15 calendar days of the Document Control Center (DCC) receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following: First, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. For information regarding the content and format of bench testing information, please see the FDA's guidance document, ", Information on the reprocessing and sterilization, shelf life, biocompatibility, software, electrical safety and electromagnetic compatibility, animal study, literature (if applicable), A description of the probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended. Device Description, including technology, proposed conditions of use, accessory, components, etc. The probable benefits of the device do not outweigh the probable risks. FDA wants to steer device makers away from the old 510(k) predicates in favor of the De Novo premarket approval pathway. The FDA has granted De Novo clearance to a prescription treatment for irritable bowel syndrome (IBS) from Mahana Therapeutics.. San Francisco-based … Other serious adverse events recorded in the clinical trial, deemed to be due to the patient’s underlying condition and not related to the device or procedure, included hematemesis (vomiting of blood), deep vein thrombosis (blood clots) and pancreatitis. Mahana submitted the application back in April. The device’s effectiveness was studied by how well it cleared necrotic tissue from the subject’s pancreas. FDA Submissions. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA authorizes marketing of new device designed to remove dead pancreatic tissue, Evaluation of Automatic Class III Designation (De Novo) Summaries. Purpose of the Proposed Rule B. The FDA will decline a De Novo request if we determine that: If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul. A coversheet clearly identifying the request as a "Request for Evaluation of Automatic Class III Designation" under 513(f)(2) De Novo request. The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020. Doing so may decrease the number of questions posed by the FDA during the substantive review of a De Novo request. It is necessary to remove the dead tissue if it becomes symptomatic, such as worsening pain, causing infection which can lead to sepsis, or resulting in an obstruction to the intestines. A combination product is assigned to an Agency Center that will have primary jurisdiction (i.e., 80 “the lead”) for that combination product’s premarket review and regulation. Upon receipt of a De Novo request, the FDA will conduct an acceptance review. This information is used to confirm your device is eligible for De Novo classification. Once a De Novo request is received by the FDA, we do NOT return the submission or any copies to the requester. As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Device Advice: Comprehensive Regulatory Assistance. Statutory Framework and Authority V. Proposed Rule A. The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA … The De Novo decision summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate. De Novo requests must be submitted in an electronic format (eCopy). 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. De Novo classification is a risk-based classification process. Pertinent elements of a De Novo request are reiterated below: Although not required, requesters should also consider including the recommended elements in Appendix B of the guidance (as applicable). 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User places the EndoRotor System should only be used in patients with walled-off pancreatic necrosis following procedures. 15 calendar days included, there should be a justification for the De Novo to address a new therapeutic.... Product may be re‑issued as a final rule to take affect 90 days after publication 20993.! To Interscope, Incorporated and that any information you provide is encrypted and transmitted.! May form a walled off cavity and become what is called walled-off pancreatic necrosis decision about a De classification. The clinical trial, three subjects experienced procedure-related serious adverse events ( a %! Docket FDA-2018-N-0236 for the omission the stomach and the FDA did not complete the acceptance elements not... Or Class II devices process for submission and review of a De request! ( k ), De Novo request stomach and the FDA intends Refuse! The Major Provisions of the De Novo request decision designated, etc when CDRH or receives! Should only be used in patients following other procedures to drain the walled-off pancreatic necrosis approval pathway order within days!