Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 4
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13Contains Nonbinding Recommendations
FDA and Industry Procedures for
Section 513(g) Requests for
Information under the Federal Food,
Drug, and Cosmetic Act
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
Purpose
The purpose of this guidance is to establish procedures for submitting, reviewing and
responding to requests for information regarding the class in which a device has been
classified or the requirements applicable to a device under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the
FD&C Act, 21 U.S.C. 360c(g).
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 cited. The use of the word should in Agency guidance means that
something is suggested or recommended, but not required.
II. Statutory Requirements for Device Classification
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