A quick rundown: the purpose of the Food and Drug Administration’s medical device pre-submission program is to provide firms with the opportunity to seek fda comment on issues about future applications before such applications are ever submitted. The applications comprise premarket approval applications (PMA), experimental device exemptions (IDE), humanitarian device exemptions (HDE), and 510(k) applications. This pre-submission program for medical devices offered by the Food and Drug Administration (FDA) also enables the FDA to offer guidance to applicants who are in the process of developing medical device clinical protocols, nonclinical protocols, and other studies while simultaneously working on the development of their medical device. Working with the Food and Drug Administration (FDA) from the conception of a medical device all the way through bringing it to market is possible via the pre-submission program for medical devices. Also going to be covered are the processes for requesting, preparing for, and running meetings with the FDA. Why should you bother to come? This online presentation is intended for medical professionals who seek comments from the Food and Drug Administration (FDA) on novel medical devices still in the prototyping stage. The Pre-Submission Program for Medical Devices offered by the Food and Drug Administration (FDA) is designed to gather FDA input prior to the submission of a medical device to the FDA. During the process of developing a medical device, the user may seek input from the Food and Drug Administration (FDA) on clinical procedures, nonclinical research, and other studies by using the fda medical device pre-submission program. areas such as these were discussed throughout the session: gaining a grasp of the FDA’s pre-submission procedure for medical devices instructions for putting together a pre-submission package for an FDA medical device Fda pre-submission meetings broken down by kind how to seek, prepare for, and run meetings with the FDA Who will benefit from this knowledge: professionals working in regulatory matters experts of sufficient caliber professionals in the clinical arena professionals in the manufacturing industry researchers and manufacturers professionals other professionals who are required to have an awareness of the FDA’s medical device pre-submission program aag incorporated is led by albert a. ghignone ms, rac as its Chief Executive Officer. His primary emphasis throughout the course of more than 30 years has been on FDA-related issues, namely in the areas of regulatory affairs, quality assurance, and clinical affairs. He is a specialist in handling all areas of the FDA approval process for pharmaceuticals, biologics, medical devices, and generic drug products. He has previous experience in all of the industry’s most important subfields, including research, quality assurance, regulatory affairs, clinical, and manufacturing. netzealous llc, doing business as globalcompliancepanel is located at 161 mission falls lane, suite 216, fremont, California 94539, United States of America. The company may be reached at 800-447-9407 or 302-288-6884. webinars@globalcompliancepanel.com. Link to the event may be found at http://bit.ly/1gaibto http://www.globalcompliancepanel.com
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