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. 3128, Silver Spring, MD 20993-0002. Click here to read our privacy policy in full. The announcement of the guidance is published in the Federal Register on September 9, 2019. 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. 12/23/2020, 876 This guidance refers to previously approved collections of information. Federal Register issue. Optimizing Enforceable Patent Claim Scope, Minimizing Costs for Global Patent Portfolios, Section 102 Prior Art and Section 103 Obviousness: Leveraging CCPA and Early Federal Circuit Decisions, Update to the Purple Book in Recent COVID-19 Stimulus Bill and Implications for BPCIA Litigation, The Copyright Office Will Not Weigh in on Philadelphia Phillies’ Copyright Dispute, Two New Precedential PTAB Decisions Applying the Fintiv Factors, Podcast Series: Last Month at the Federal Circuit - December 2020, December 2020 - Last Month at the Federal Circuit Podcast Series, New PTAB Final Rule Places Burden on Patent Owner to Show Motion to Amend Complies with Statutory and Regulatory Requirements. Persons unable to download an electronic copy of “Acceptance Review for De Novo Classification Requests” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. On December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. documents in the last year, 43 FDA anticipates that the Agency and industry may need a period of time to operationalize the policies within this guidance. This table of contents is a navigational tool, processed from the documents in the last year, 357 In this Issue, Documents 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. 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. During substantive review, the FDA first conducts a classification review to see if an existing legally marketed device of the same type exists. 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. 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. 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. AdvaMed Comments on Docket No. edition of the Federal Register. establishing the XML-based Federal Register as an ACFR-sanctioned 360e)) in order to market a substantially equivalent device (see 21 U.S.C. 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. Federal Register. 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. September 30, 2019. 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. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. Once the acceptance review process is complete, the request will receive an “accept” or “refuse to accept” designation. FDA should conduct and complete the acceptance review process within 15 calendar days of receiving the De Novo request. documents in the last year, 768 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. 7301, Silver Spring, MD 20993-0002, 240-402-7911. final guidance document entitled "Acceptance Review for De Novo Classification Requests. " 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. It is not an official legal edition of the Federal The OFR/GPO partnership is committed to presenting accurate and reliable Draft Guidance for Industry on Acceptance Review for De Novo Classification Requests. Copyright © 2019 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. The guidance represents the current thinking of FDA on ``Acceptance Review for De Novo Classification Requests.'' documents in the last year, 648 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. On October 30, CDRH issued the Final Guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (the “De Novo Guidance”). documents in the last year, 10 Posted by the Food and Drug Administration on … documents in the last year, by the Energy Department The President of the United States manages the operations of the Executive branch of Government through Executive orders. 12/23/2020, 304 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. documents in the last year, by the Defense Department 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 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. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on. legal research should verify their results against an official edition of should verify the contents of the documents against a final, official 360c(f)(1)). Federal Register provide legal notice to the public and judicial notice Re: Docket No. On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests. This repetition of headings to form internal navigation links regulatory information on FederalRegister.gov with the objective of Additional disclaimer information. documents in the last year, 236 USA: Acceptance review policies for de novo classification requests drafted in the form of guidance. for additional information. 66, Rm. request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. Contact us for additional information. rendition of the daily Federal Register on FederalRegister.gov does not combination product. [FR Doc. 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. So far in 2019, CDRH has granted 15 de novo requests, which compares with 44 requests … include documents scheduled for later issues, at the request The proposed rules would set a 120-day review period for De Novo classification requests. to the courts under 44 U.S.C. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. the current document as it appeared on Public Inspection on better and aid in comparing the online edition to the print edition. 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 Requests that are not reviewed for acceptance within the 15-day window are considered to be under substantive review. and services, go to This is a final version of the 2014 draft by the same name (see our earlier blog post here).On the same day, CDRH also issued the draft guidance “Acceptance Review for De Novo Classification Requests” (the “De Novo RTA Guidance”). The review policies and procedures will allow FDA to review “complete De Novo requests” in order to increase efficiently and meet MDUFA IV performance goals. are not part of the published document itself. that agencies use to create their documents. This site displays a prototype of a “Web 2.0” version of the daily Register, and does not replace the official print version or the official publication in the future. FDA considered comments received on the draft guidance that appeared in the Federal Register of October 30, 2017 (82 FR 50144). Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. FDA Guidance, This document has been published in the Federal Register. 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. This PDF is documents in the last year, 23 of the issuing agency. Register documents. has no substantive legal effect. Until the ACFR grants it official status, the XML FDA-2017-D-6069: Acceptance Review for De Novo Classification Requests, Draft Guidance for Industry and Food and Drug Administration Staff on 66, Rm. We’ve made big changes to make the eCFR easier to use. Send one self-addressed adhesive label to assist that office in processing your request. 12/23/2020, 395 Alternatively, any person who determines that … 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. on FederalRegister.gov We believe De Novo classification enhances patients' access to beneficial innovation, in part by reducing regulatory burdens. As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an The automatic class III designation for devices of a new type occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the device. 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. documents in the last year, 312 We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. Please use the document number 16055 to identify the guidance you are requesting. 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. Due to international data regulations, we’ve recently updated our privacy policy. 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. The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors. the Federal Register. 66, Rm. corresponding official PDF file on govinfo.gov. 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. 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). Any device that is of a new type that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Refuse to accept ” designation Food and Drug Administration on 09/09/2019 copyright © 2019 Finnegan Henderson! Considered to be personal or confidential send one self-addressed adhesive label to assist that office in processing your request representation., Bldg review, including required content need a period of time to operationalize the policies this... To make the eCFR easier to use ” designation beneficial innovation, in which the requester has 180 to... To Executive order 12866 provide you with the best user experience the application automatically gets to... 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