FDA Classification of Products as Drugs and Devices and Additional Product Classification Issues

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Classification of Products as Drugs and Devices and Additional Product Classification Issues[附网盘链接]由Food&Drug Administration于当前发布，适用于U.S。

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Classification of Products as Drugs and Devices & Additional Product Classification Issues: 1

Guidance for Industry and FDA 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 the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page of this guidance. 1

I. INTRODUCTION FDA regularly receives questions from medical product sponsors concerning the 2

classification of their products. We believe that efficient, effective regulation is facilitated by providing guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities. In addition, providing as much clarity and predictability as possible with respect to product classifications should enable informed planning for product development. Accordingly, we have prepared this guidance to make the Agency’s current thinking concerning certain product classification issues more readily and widely available. While issues have arisen relating to whether a product should be classified as a drug, device, biological product, or combination product, most of these issues have related to whether 3

a product should be classified as either a drug or a device. Accordingly, this guidance focuses 4 5

particularly on cases in which a product may be classified as a drug or device. This guidance also addresses additional issues relating to product classification, including how to obtain classification determinations from FDA for medical products. This guidance is organized into two substantive sections. 1

This guidance has been prepared by the Office of Combination Products in consultation with the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research. 2

Please note that “classification” as used in this guidance refers to a product’s designation as a drug, device, biological product, or combination product. This is distinct from the use of the term “classification” in reference to the class (Class I, II, or III) of a device as described in section 513(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 3

This guidance addresses the definitions for the terms drug, device, and biological product in section III. The term “combination product” is defined in 21 CFR 3.2(e). For further information regarding the definition for the term combination product and the regulation of combination products, please visit the webpage for the Office of Combination Products at www.fda.gov/CombinationProducts/default.htm. 4

The guidance’s discussion of the classification of products is also relevant to classification of the constituent parts of a combination product. 5

This guidance focuses on classification of products for human use. Distinct considerations may apply in determining how to classify a product intended for use in animals. 2

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