FORM FDA 3514 (1/13). CDRH PREMARKET REVIEW SUBMISSION COVER SHEET - njpa-2025

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The document is the May 2009 issue of 'InPrint,' a publication by the New Jersey Press Association (NJPA). It includes announcements about upcoming events such as the Legislative Correspondents Club Show and various NJPA meetings. The issue highlights awards given to journalists, including Stefanie Dazio, who received scholarships for her achievements. It discusses legislative actions against home contractors for advertising violations and features articles on new revenue opportunities for newspapers through webinars. Additionally, it covers technological advancements at Rutgers University funded by alumni donations and reports on the financial challenges faced by AbitibiBowater, a major newsprint producer. The document also contains classified ads for job openings in journalism and advertising.

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What is FDA premarket submission?

A premarket notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain U.S. marketing clearance.

What is the difference between 501k and PMA?

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

Which FDA office has primary responsibility for medical device premarket submissions?

The FDAs Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

What is the FDA form 3514?

Form FDA 3514, or the CDRH Premarket Review Submission Cover Sheet, is a voluntary form used to help provide basic administrative info for all types of premarket notification submissions.

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