premarket notification requirements concerning:上市前通知要

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

MAY 2 2006 Premarket Notification [510(k)] Summary:2006 5

Premarket Notification [510(k)] Summary (Continued)6 Summary of the technological characteristics of the device compared tothe predicate deviceThe Kimberly-Clark Procedure Gown and the Kimberly-Clark Impervious OpenBack Gown (K880382) are manufactured with similar materials of construction Neither gown is intended to be worn during surgical procedures as both gownsare provided as non-sterile

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

FDA

For Class III devices a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976 or substantially equivalent to such a device) and PMA's have not been called for In that case a 510k will be the route to market

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

fda 21 cfr 812 ide (fda)

An IDE approved under 812 30 or consideredapproved under 812 2(b) exempts a device from the requirements of thefollowing sections of the Federal Food Drug and Cosmetic Act (the act) andregulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

FDA 21 CFR 812 IDE (fda)_

An IDE approved under 812 30 or considered approved under 812 2(b) exempts a device from the requirements of the following sections of the Federal Food Drug and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act registration listing and premarket notification under section 510 performance standards under section 514 premarket

Premarket Notification Requirements Concerning:

Premarket Notification Requirements Concerning: : 2500 : Contains Nonbinding Recommendations 1 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff Document issued on December 9 2015

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