510（k)文件通常包含哪些内容？

以下是510K涉及的相关内容，如需办理FDA注册/认证/授权代表等等，欢迎详询。

·         Medical Device User Fee Cover Sheet

·         CDRH Premarket Review Submission Cover Sheet

·         Certification of Compliance with ClinicalTrials.gov Data Bank

·         Cover letter as described in the format guidance

·         Table of Contents (recommended)

·         Indications for Use. See Determination of Intended Use for 510(k) Devices (Update to K98-1) for additional information on indications for use.

·         510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93)

·         Standards Data Report for 510(K)s.

·         Truthful and Accuracy Statement (21 CFR 807.87(k))

·         Class III Certification and Summary for Class III devices (21 CFR 807.94)

·         Items required under 21 CFR 807.87 (Information required in a Premarket Notification submission), including

o    the name of device, include the trade or proprietary name, if any, and the common or usual name or classification name of the device. Provide what you believe to be the classification of the device, approprate panel (e.g. cardiovascular, dental, etc.), and product code, if known.

o    description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable

o    comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

o    intended use of the device,

o    proposed label, labeling, and advertisements for the device and directions for use.

·         Information on sterilization, biocompatibility, expiration date, etc., if applicable.