Description :FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts. Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together for your successful submission to the FDA compliant with the FDA’s eCopy and RTA policy. This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. In this presentation, 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 presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.Areas Covered in the Session :Laws And RegulationsDefinitionsDevice ClassificationPredicatesRecent FDA Final 510(k) GuidanceWhen a 510(k) Is Required510(k) RequirementsSubstantial Equivalence: Factors to Consider and Special ConsiderationsAddressing e-Copy And RTA Policy RequirementsCommon Mistakes for eCopy and RTA Policy RequirementsCommon 510(k) Pitfalls: How to Prevent Them: Dos and Don’tsWhat to Ensure While Preparing for a 510(k) ApplicationResponding to FDA’s Request of Additional Information.Resolving Different Opinions and InterpretationsBest Practices for 510(k) Contents and FormatPASS-IT Recommendations: Dos and Don’ts Who 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$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458