This session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. David 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 session 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 how to identify predicates: key factors510(k) program: when the requirement is of 510(K)Regulatory requirements510(k): requirements, contents and formatSubstantial equivalence: special considerationsThe task of addressing e-Copy and RTA policy requirementsSome of the common mistakes for RTA policy requirementsApplicable standards and guidanceCommon pitfalls and how to prevent them: dos and don’tsWhat to ensure while preparing for a 510(k) applicationResponse to FDA’s request of additional informationResolving some of the different opinions and interpretations: dos and don’tsSpeaker’s practical, actionable and sustainable solutions (PASS)Best Practices to achieve compliance and to stay compliant: dos and don’tsPASS-IT suggestions and recommendationsWho Will Benefit:Medical device quality and compliance professionalsPharmaceutical compliance professionalsQualityRegulatory affairsCEOsVPsAttorneysClinical affairsResearch & DevelopmentConsultantsContractors/subcontractorsAnyone interested in the 510(K) mattersPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299