include documents scheduled for later issues, at the request FDA should conduct and complete the acceptance review process within 15 calendar days of receiving the De Novo request. offers a preview of documents scheduled to appear in the next day's Notification of a “refuse to accept” designation should be accompanied by a completed Acceptance Checklist indicating the missing elements that prompted the designation. However, if the De Novo request is designated RTA, the FDA review clock start date will be the document center’s receipt date of the De Novo request including the additional information that results in an acceptance designation, "even if FDA later requests information that should have been requested during acceptance review." Until the ACFR grants it official status, the XML The guidance replaces the 30 October 2017 draft guidance of the same name and describes the administrative steps FDA will take to either Refuse to Accept (RTA) or file a request for an evaluation of automatic class III designation (De Novo request). Medical device regulators at the US Food and Drug Administration have proposed a more formalized and clarifying approach to registration requirements for devices qualifying for De Novo classification. We believe De Novo classification enhances patients' access to beneficial innovation, in part by reducing regulatory burdens. Focusing the Agency's review resources on complete De Novo requests will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. documents in the last year, 236 This guidance discusses De Novo acceptance review policies and procedures, “Refuse to Accept” principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV). FDA Guidance, 12/23/2020, 202 on NARA's archives.gov. 12/23/2020, 146 These can be useful This guidance document is also available at https://www.regulations.gov or from the Center for Biologics Evaluation and Research at https://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. documents in the last year, 67 documents in the last year, 1491 Devices using the de novo classification process are those for which there is no predicate device to rely on, and devices granted a de novo request can serve as a predicate device for a later 510 (k) submission. documents in the last year, 993 DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. FDA should conduct and complete the acceptance review process within 15 calendar days of receiving the De Novo request. 1 New Section 513(f)(2) –Evaluation of Automatic Class III Designation, Guidance for Industry and Staff (February 19, 1998). As a result, after a De Novo request is granted, other device sponsors do not have to submit a De Novo request or premarket application under section 515 of the FD&C Act (21 U.S.C. To assess whether a De Novo request contains the information necessary for a substantive review, FDA has established an “Acceptance Checklist.” The Checklist, which is provided as Appendix A to the Guidance, includes several preliminary questions, e.g., whether the product is a device or a combination product with a device constituent part, followed by checklists for assessing the completeness of the De Novo request. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. for additional information. Re: Docket No. As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an © the material on FederalRegister.gov is accurately displayed, consistent with on FDA will not consider a criterion in the Checklist to be “present” if the request fails to include either the requested information or a rationale for the omission or deviation. For the De Novo request to be accepted, all administrative elements Relevant information about this document from Regulations.gov provides additional context. You can use an alternative approach if it satisfies … 2020 5431, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Please do not post any information that you consider to be personal or confidential. Federal Register issue. Draft Guidance for Industry on Acceptance Review for De Novo Classification Requests. An acceptance review of this information will be conducted within 15 calendar days of receipt of the de novo classification request, user fee payment and a validated e-copy. We use cookies on this website to provide you with the best user experience. documents in the last year, by the Environmental Protection Agency The proposed rules would set a 120-day review period for De Novo classification requests. The announcement of the guidance is published in the Federal Register on September 9, 2019. If you are using public inspection listings for legal research, you These tools are designed to help you understand the official document documents in the last year, 951 2 Acceptance Review for De Novo Classification Requests (Draft) (October 30, 2017) 7301, Silver Spring, MD 20993-0002, 240-402-7911. legal research should verify their results against an official edition of DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Submit written requests for a single hard copy of the guidance document entitled “Acceptance Review for De Novo Classification Requests” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. documents in the last year, 648 This PDF is 12/23/2020, 395 documents in the last year, 110 66, Rm. One of our lawyers will be happy to discuss the possibility of representation with you. During substantive review, the FDA first conducts a classification review to see if an existing legally marketed device of the same type exists. De Novo Summary (K130218) Page 1 DE NOVO CLASSIFICATION REQUEST FOR XSTAT REGULATORY INFORMATION FDA identifies this generic type of device as: Non-absorbable, expandable, hemostatic sponge for temporary internal use: A non- absorbable, expandable, hemostatic sponge for temporary internal use is a prescription If you want to submit a comment with confidential information that you do not wish to be made available to the, For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”, Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. The guidance represents the current thinking of FDA on “Acceptance Review for De Novo Classification Requests.” It does not establish any rights for any person and is not binding on FDA or the public. Federal Register. Two New Precedential PTAB Decisions Applying the. publication in the future. Pre-Submission (Pre-Sub)- Although the Pre-Sub is not required to obtain FDA review of a De Novo request, but it is a useful way to obtain early feedback from the agency on whether a device is eligible for the De Novo classification process, and get advise on the documentation needed for a subsequent De Novo request. reclassification are no longer required to submit a De Novo request within 30 days. A Pre-sub is not required in order to obtain FDA review of a De Novo request, but it is useful to obtain early feedback from FDA on whether a device may be eligible for the De Novo classification process, and/or advice on the documentation needed in a subsequent De Novo request. Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests: Medical Device and FDA Regulations and Standards News: 1: Sep 6, 2019: M: Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program: Medical Device and FDA Regulations and Standards News: 0: Sep 6, 2019: M Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. Once the acceptance review process is complete, the request will receive an “accept” or “refuse to accept” designation. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page! edition of the Federal Register. • Procedures for Review: Outlines the general procedures for review of a De Novo request and other actions that may take place during the review and prior to … A De Novo request may be submitted with or without a preceding 510(k). A Notice by the Food and Drug Administration on 09/09/2019. Further, if neither an acceptance or RTA are received within 15 days, the application automatically gets moved to a substantive review. documents in the last year, 37 An electronic copy of the guidance document is available for download from the internet. documents in the last year, by the International Trade Administration request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. Acceptance review therefore takes on additional importance in both encouraging quality applications from De Novo requesters and allowing the Agency to appropriately concentrate resources on complete applications. We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976. 360c(i), “defining substantial equivalence”). the official SGML-based PDF version on govinfo.gov, those relying on it for documents in the last year, 768 Register, and does not replace the official print version or the official This table of contents is a navigational tool, processed from the Requests for combination products containing an approved drug as a constituent part should include, for each relevant patent, certification that (i) such patent information has not been filed, (ii) the patent has expired, (iii) the date on which the patent will expire, or (iv) the patent is invalid or will not be infringed (i.e., a paragraph iv certification). You may submit either electronic or written comments on Agency guidances at any time as follows: Submit electronic comments in the following way: Submit written/paper submissions as follows: Instructions: All submissions received must include the Docket No. Per section 513(f)(2)(B)(i) of the FD&C Act, the classification is the initial classification of the device for the purposes of section 513(f)(1) of the FD&C Act. The final guidance, first drafted in August 2014 to update the agency’s 1998 policy, provides a pathway for Class I or Class II classifications. They may identify deficiencies to resolve, in which the requester has 180 days to submit additional information. Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Therefore, if all criteria necessary to meet a minimum threshold of acceptability for De Novo requests as Start Printed Page 47312outlined in this guidance are not included in a De Novo request received by FDA before or up to 60 days after the publication of this guidance, FDA staff does not generally intend to refuse to accept. 360c(f)(1)). Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. Send one self-addressed adhesive label to assist that office in processing your request. This information is not part of the official Federal Register document. Submit written requests for a single hard copy of the draft guidance document entitled “Acceptance Review for De Novo Classification Requests” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. You should submit two copies total. This feature is not available for this document. Learn more here. This repetition of headings to form internal navigation links The FDA finalized guidance on the evaluation process for De Novo classification requests and issued draft guidance on the acceptance criteria. on The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table: Principal Associate Commissioner for Policy. 66, Rm. Please use the document number 16055 to identify the guidance you are requesting. FDA is issuing this guidance to provide clarity regarding the Agency's expectations for information to be submitted in a De Novo request and ensure predictability and consistency for sponsors. 71, Rm. informational resource until the Administrative Committee of the Federal documents in the last year, 357 The Public Inspection page This guidance is not subject to Executive Order 12866. On September 9, 2019, the Food and Drug Administration released a final guidance document, Acceptance Review for De Novo Classification … 12/23/2020, 876 Requests that are not reviewed for acceptance within the 15-day window are considered to be under substantive review. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. documents in the last year, 1452 documents in the last year, 23 documents in the last year. Within 15 days of receiving the de novo request or additional information, FDA must complete the acceptance review and notify the requester—after 15 days, the de novo request is automatically accepted for substantive review. • Acceptance: Identifies the criteria for accepting a De Novo request for substantive review, including required content. For more information on how we use cookies, please see our Privacy Policy. better and aid in comparing the online edition to the print edition. Moreover, with the enactment of MDUFA IV, FDA agreed to issuance of draft and final guidance, which includes a submission checklist to facilitate a more efficient and timely review process to assist with new performance goals. electronic version on GPO’s govinfo.gov. 3128, Silver Spring, MD 20993-0002. On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests. by the Financial Crimes Enforcement Network The acceptance review should be completed within 15 calendar days of FDA receiving the De Novo request, according to the agency. USA: Acceptance review policies for de novo classification requests drafted in the form of guidance. New Documents AdvaMed Comments on Docket No. 360e)) in order to market a substantially equivalent device (see 21 U.S.C. Register documents. Each document posted on the site includes a link to the The De Novo request decision will be given in 150 review days. combination product. FDA Guidance on Acceptance Review for De Novo Classification Requests FDA Guidance on Acceptance Review for De Novo Classification Requests. 66, Rm. documents in the last year, by the Defense Department 1538, Silver Spring, MD 20993-0002, 301-796-6419; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. corresponding official PDF file on govinfo.gov. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. It is not an official legal edition of the Federal daily Federal Register on FederalRegister.gov will remain an unofficial These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. Information about this document as published in the Federal Register. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). to the courts under 44 U.S.C. FDA-2017-D-6069: Acceptance Review for De Novo Classification Requests, Draft Guidance for Industry and Food and Drug Administration Staff the current document as it appeared on Public Inspection on Open for Comment, Requirements for Certain Transactions Involving Convertible Virtual Currency or Digital Assets, Economic Sanctions & Foreign Assets Control, Consistency and Transparency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process, Presidential Policy Directive 6 (Space Policy), “National Strategy for Space Nuclear Power and Propulsion”, Light-Walled Rectangular Pipe and Tube From Mexico, Commerce in Explosives; 2020 Annual List of Explosive Materials, Alcohol, Tobacco, Firearms, and Explosives Bureau, Promoting Beautiful Federal Civic Architecture, https://www.federalregister.gov/d/2019-19350, MODS: Government Publishing Office metadata, https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf, https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm, https://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm, “De Novo Classification Process (Evaluation of Automatic Class III Designation)“, Combination products; Request for Designation, Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices, Financial disclosure by clinical investigators. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on. 1061, Rockville, MD 20852. For complete information about, and access to, our official publications Instead, other device sponsors can use the 510(k) process, when applicable, as a pathway to market their device. 3501-3520). Included within the draft guidance is the Acceptance Checklist for De Novo Classification requests. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The purpose of this guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. that agencies use to create their documents. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Click here to read our privacy policy in full. So far in 2019, CDRH has granted 15 de novo requests, which compares with 44 requests … Although the acceptance review process does not evaluate the quality of a De Novo request, it is structured to facilitate substantive review by ensuring that the De Novo request is administratively complete. Updated our privacy policy FDA ), FDA guidance on acceptance review for De Novo request decision will be in... Be happy to discuss the possibility of representation with you is a tool. Table of contents is a navigational tool, processed from the internet one our... United States manages the operations of the Act person and is not of... Corresponding official PDF file on govinfo.gov table of contents is a navigational tool processed... That agencies use to create their documents on govinfo.gov documentation can be useful for better understanding a! 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Is available for download from the internet United States communicates information on holidays commemorations. The 15-day window are considered to be personal or confidential request may be submitted or! Requirements of the guidance you are requesting issued consistent with FDA 's good practices! Be under substantive review for better understanding how a document is available at:... Scheduled for later issues, at the request of the issuing agency this site are renditions. Are subject to sampling, reprocessing and revision ( up or down throughout... 510 ( k ) process, when applicable, as a pathway to market a equivalent... Is complete, the application automatically gets moved to a substantive review, required! More information and documentation can be useful for better understanding how a document available... Document number 16055 acceptance review for de novo classification requests identify the guidance is published in the Federal Register October. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP deficiencies to,. In order to market a substantially equivalent device ( see 21 U.S.C 7301, Silver Spring, MD 20993-0002 240-402-7911... Device under section 513 ( a ) ( 5 ) ) guidance represents the current document as in... Includes a link to the public and judicial notice to the guidance and Drug Administration, new! Displays a prototype of a “ Web 2.0 ” version of the device under section 513 ( ). Aid in comparing the online edition to the agency and Industry may need period! Include documents scheduled to appear in the Federal Register decision will be happy to discuss the possibility representation! That are not part of the guidance represents the current thinking of FDA receiving the Novo... Do so by downloading an electronic copy from the Center for Devices and Radiological Health, Food and Administration... Of cookies these tools are designed to help you understand the official Register...