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FDA Acceptance Review for De Novo Classification Requests

蒋千琴 10/3/2021 浏览 351 FDA 美国

标准简介

Acceptance Review for De Novo Classification Requests[附网盘链接]由Food&Drug Administration于不久之前发布，适用于美国。

标准截图

Acceptance Review for De Novo Classification Requests[附网盘链接]
Acceptance Review for De Novo Classification Requests[附网盘链接](截图)

 

标准文档说明

标准文档类型为Acceptance Review for De Novo Classification Requests[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Acceptance Review for De Novo Classification Requests Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction The purpose of this document 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 1

should be accepted for substantive review. 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. Moreover, with the enactment of the Medical Device User Fee Amendments of 2017 2

(MDUFA IV), FDA agreed to performance goals based on the timeliness of reviews, as well as guidance that includes a submission checklist to facilitate a more efficient and timely review process (see Section II.E. of the MDUFA IV Commitment Letter). Acceptance review therefore takes on additional importance in both encouraging incoming quality applications from De Novo requesters and allowing the Agency to appropriately concentrate resources on complete applications. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are 1

For more information regarding the De Novo review process, please see the FDA guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-

evaluation-automatic-class-iii-designation. 2

See Title II of the FDA Reauthorization Act of 2017 (Public Law 115-52).

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