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 CoverSheet

·         CDRH Premarket Review SubmissionCover Sheet

·         Certification of Compliance withClinicalTrials.gov Data Bank

·         Cover letter as described in theformat guidance

·         Table of Contents(recommended)

·         Indications for Use. SeeDetermination 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) or510(k) Statement (21 CFR 807.93)

·         Standards Data Report for510(K)s.

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

·         Class III Certification andSummary 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 orproprietary name, if any, and the common or usual name orclassification name of the device. Provide what you believe to bethe classification of the device, approprate panel (e.g.cardiovascular, dental, etc.), and product code, if known.

o    description of the device, include devicespecifications and reference applicable guidance documents, specialcontrols, or standards; photographs or engineering drawings shouldbe supplied, if applicable

o    comparison with a predicate device(s), indicatingsimilarities and/or differences accompanied by data, asappropriate; this information may include an identification ofmaterials, design considerations, energy expected to be used ordelivered by the device, and a description of the operationalprinciples of the device.

o    intended use of the device,

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

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