FDA Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff

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Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff[附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。

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Breakthrough Devices Program 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. 1

I. Introduction This guidance document describes policies that FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3), as created by st

section 3051 of the 21 Century Cures Act (Cures Act) (Public Law 114-255) and amended by section 901 of the FDA Reauthorization Act of 2017 (Public Law 115-52) (the “Breakthrough Devices Program”). The Breakthrough Devices Program is a voluntary program for certain 2

medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo request”). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing 3

authorization, consistent with the Agency’s mission to protect and promote public health. The Breakthrough Devices Program supersedes the Expedited Access Pathway (EAP), which was launched in 2015. The Breakthrough Devices Program contains features of the EAP as well as the Innovation Pathway (first piloted in 2011; the pilot is now discontinued), both of which were intended to facilitate the development and expedite the review of breakthrough technologies. Due to consistency in vision and designation criteria between the precursor EAP Program and the Breakthrough Devices Program, FDA now considers devices granted designation under the EAP to be part of the Breakthrough Devices Program. 1

The Office of Combination Products (OCP) and the Center for Drug Evaluation and Research (CDER) were consulted in the preparation of this guidance. 2

A combination product is defined in 21 CFR 3.2. For purposes of this guidance, device-led combination products refer to combination products subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. 3

Statement of FDA Mission can be found at https://www.fda.gov/AboutFDA/WhatWeDo/.

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