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Webinar On - The FDA 510(k): Q-Submission, Preparation and Submission

Compliance Trainings

This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.   This webinar is intended to discuss what and how to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable.  It is further intended to discuss 510(k) contents and format compliant with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation and submission in a less-burdensome, effective manner.   In this webinar, the speaker will share what he has learned from his own experience and also based on his analysis of various different types of 510(k)s that have been recently cleared. Areas Covered in the Session: Statute(s) And RegulationsDefinitionsWhen 510(k)s Are RequiredIdentifying Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc. Device Classification And PredicatesObtaining an FDA FeedbackSubstantial EquivalenceAddressing e-Copy And RTA Policy RequirementsApplicable Standards And Guidances510(K) Contents And FormatResponding To FDA’s Request Of Additional Information.Resolving Different Opinions and InterpretationsBest Practices: Practical, Actionable and Sustainable SolutionsConclusions Who Will Benefit: Regulatory AffairsResearch & DevelopmentQuality AssuranceQuality ControlQuality System ManagementCROsConsultantsContractors/SubcontractorsSenior managementAnyone interested in 510(k) matters


4 Mar 2014 @ 12:00 pm

4 Mar 2014 @ 01:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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