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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 12
First page : ( 5675) Last page : ( 5780)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.01028.4

510(k) Premarket Notification

Santhosh S.*, Dr. Kamaraj R.

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-6030203, Kanchipuram, Tamilnadu, India

*Corresponding Author E-mail: santhoshpharmara003@gmail.com

Online published on 18 May, 2019.

Abstract

Premarket approval application is not essential but 510(k) must submit to FDA to market medical device in the U.S for human use. To conclude or to determine the device is substantially equivalent to the device which is already marketed. After getting a 510(k) clearance immediately device can be marketed by submitter. In such case where already marketed device is changed in its safety or effectiveness it might affect the manufacturer and there is essential to file a 510(k) submission by manufacturer. Manufacturer should submit 510(k) to FDA in case of modifications or changes in use, chemical composition, design, energy source etc,.510(k) submission depends upon the comparison between the already marketed device and new device in the U.S, to ascertain whether the device is safety and effectiveness.2

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Keywords

Medical Device, Premarket Notification, 510(k), Safe, Effective, Labeling.

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