FDA Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry

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Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry[附网盘链接]是于之前发布的FDA标准，适用于US。

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Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry 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 responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies. st 1

Section 3034 of the 21 Century Cures Act (Cures Act) mandates that FDA issue guidance clarifying how FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies, as such term is used in section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(g)) and which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs.” Accordingly, this guidance discusses what FDA will consider when evaluating the devices used with RMATs. This document includes information about the Agency’s current thinking regarding a wide range of concepts related to the regulation of devices, as they apply to devices used in the recovery, isolation, and delivery of RMATs. Specifically, this guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue 2

products; what, if any, intended uses or specific attributes would result in a device used with a 3

regenerative therapy product to be classified as a Class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. 1

Public Law 114-255. 2

For purposes of this guidance, the term “combination device and cell or tissue products” is not necessarily limited to “combination product” as defined under 21 CFR Part 3. 3

As explained in section III of this guidance, we are unable to provide a definitive list of intended uses or specific attributes that would result in a device used with an RMAT being classified as a Class III device, but have instead addressed this requirement of section 3034 of the Cures Act by providing information about characteristics of Class III devices.

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