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Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 3

Contains Nonbinding Recommendations

Table of Contents

Introduction .......................................................................................................................................................... 1

II.

Statutory Requirements for Device Classification ................................................................................................ 1

III.

Obtaining Information About a Device ............................................................................................................ 3

General Information .............................................................................................................................................. 3

Section 513(g) Request for Information ............................................................................................................... 3

Formal Jurisdictional Determinations within FDA ............................................................................................... 5

IV.

Submitting a 513(g) Request for Information ................................................................................................. 5