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Webinar on The FDA 510(k) and Q-Submission: Best Practices

How to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions

Description :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 how to put together a pre-submission (Q-submission) 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.The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA's eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner.In this webinar, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. This webinar is a must for regulatory professionals working in medical device industry including those who are interested in the topic.Areas Covered in the Session :Statute(s) And RegulationsDefinitionsDevice Classification And Predicates510(k) ProgramWhen 510(k)s Are RequiredApplicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and FormatSubstantial Equivalence: Factors to Consider and Special ConsiderationsAddressing e-Copy And RTA Policy RequirementsApplicable Standards and Guidance510(k) Contents And FormatCommon Pitfalls and How to Prevent ThemWhat to Ensure While Preparing Your Q-Submission and a 510(k) ApplicationResponding to FDA's Request of Additional Information.Resolving Different Opinions and InterpretationsBest Practices for a Q-submissionBest Practices for a 510(k) Preparation, Submission and ClearanceSpeaker’s PASS-IT suggestions and recommendationsConclusionsWho Will Benefit:Regulatory AffairsResearch & DevelopmentQuality AssuranceQuality ControlQuality System ManagementCROsConsultantsContractors/SubcontractorsSenior managementAnyone interested in 510(k) matters


3 Feb 2016 @ 01:00 pm

3 Feb 2016 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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