{"186751":{"#nid":"186751","#data":{"type":"event","title":"Bullet Proof 510(k) Webinar","body":[{"value":"\u003Cp\u003E\u003Cstrong\u003EA webinar on the latest FDA proposed changes to the process\u003C\/strong\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Cem\u003ENOTE: This webinar can only be viewed at the designated time\/place and cannot be broadcasted to individual workstations.\u003C\/em\u003E\u003Cbr \/\u003E\u0026nbsp;\u003Cbr \/\u003EOverview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. \u003Cbr \/\u003E\u003Cbr \/\u003EThere are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the \u0022New 510(k) Paradigm\u0022 to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.\u003Cbr \/\u003E\u003Cbr \/\u003EObjectives:\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003EKnow the differences between the Traditional, Special and Abbreviated submissions\u003C\/li\u003E\u003Cli\u003EUnderstand Substantial Equivalence and how it is applied\u003C\/li\u003E\u003Cli\u003EWho is required to submit the application to FDA\u003C\/li\u003E\u003Cli\u003EWhere to submit the 510(k) and what to expect with the review and approval process\u003C\/li\u003E\u003Cli\u003EWhen it is and is not required if you are a device company\u003C\/li\u003E\u003Cli\u003EExemptions to the submission process and special considerations\u003C\/li\u003E\u003Cli\u003EHow to locate a \u0022predicate\u0022 device and go through the content and format of the 510(k)\u003C\/li\u003E\u003Cli\u003EUnderstand the De Novo process and the expectations for possibly marketing a low risk device\u003C\/li\u003E\u003Cli\u003EUnderstand the potential impact of FDA\u0027s proposed changes to the 510(k) process and why manufacturers need to pay attention\u003C\/li\u003E\u003C\/ul\u003E\u003Cp\u003E\u0026nbsp;\u003Cbr \/\u003EWho will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. \u003Cbr \/\u003E\u003Cbr \/\u003EThose who will benefit include:\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003ER\u0026amp;D\u003C\/li\u003E\u003Cli\u003EQuality Assurance\u003C\/li\u003E\u003Cli\u003EQuality Control\u003C\/li\u003E\u003Cli\u003EProduction\u003C\/li\u003E\u003Cli\u003EOperations\u003C\/li\u003E\u003Cli\u003EEngineering\u003C\/li\u003E\u003Cli\u003ECompliance and Regulatory Affairs\u003C\/li\u003E\u003Cli\u003EAll Levels of Management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA\u0027s proposed changes to the 510(k) process.\u003C\/li\u003E\u003C\/ul\u003E","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":[{"value":"\u003Cp\u003EBullet Proof 510(k) - A webinar on the latest changes to the process\u003C\/p\u003E","format":"limited_html"}],"field_summary_sentence":[{"value":"A webinar on the latest FDA proposed changes to the process"}],"uid":"27195","created_gmt":"2013-01-25 10:41:23","changed_gmt":"2016-10-08 02:02:15","author":"Colly Mitchell","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2013-02-13T12:00:00-05:00","event_time_end":"2013-02-13T13:30:00-05:00","event_time_end_last":"2013-02-13T13:30:00-05:00","gmt_time_start":"2013-02-13 17:00:00","gmt_time_end":"2013-02-13 18:30:00","gmt_time_end_last":"2013-02-13 18:30:00","rrule":null,"timezone":"America\/New_York"},"extras":[],"groups":[{"id":"1292","name":"Parker H. Petit Institute for Bioengineering and Bioscience (IBB)"}],"categories":[],"keywords":[{"id":"56401","name":"Bullet Proof 510(k)"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[{"id":"1795","name":"Seminar\/Lecture\/Colloquium"}],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Ca href=\u0022mailto:bkilbou@emory.edu\u0022\u003EBarbara Kilbourne\u003C\/a\u003E\u003C\/p\u003E","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}