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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
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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