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What to include in Traditional 510(k) Filing for Medical Devices

BayBiotech.NET
A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):
 the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.
 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.
 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.
 intended use of the device,
 proposed label, labeling, and advertisements for the device and directions for use.
 Information on sterilization, biocompatibility, expiration date, etc., if applicable.
Important elements of a Traditional 510(k) filing include:
• Medical Device User Fee Cover Sheet (Form FDA 3601).
• CDRH Premarket Review Submission Cover Sheet
• Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674
• Cover letter
• Table of Contents (recommended)
• 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 - FDA 3654. Submit this form if your 510(k) references a national or international standard.
• Truthful and Accuracy Statement (21 CFR 807.87(k))
• Class III Certification and Summary for Class III devices (21 CFR 807.94)
For more details on the procedure and forms visit official FDA website at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070202.htm

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