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FDA 510(k) Requirements, Submission, and Clearance

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON, canada Ontario

43.5833752499621 -79.70855712890625

Description

Description :This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.From this webinar, you willGain and receive great guidance on 510(k) preparation, submission and clearanceGet the latest informationLearn the critical areas and common mistakesImprove your current practiceRecognize what is importantBecome better aware of and get familiar with the 510(k) process and much more.Areas Covered in the Session :Applicable statute(s), regulations, and definitionsDevice classificationWho is subject to a 510(k)FDA guidance for 510(k) programWhat actions require a 510(k) including three types of 510(k)sHow to identify a predicate(s), if any.510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDAe-Copy ProgramProduct type-specific 510(k) contents-recently clearedWhat to include and address in 510(k) submissions.510(k) contents and formatHow to present scientific, technical, and/or clinical data.How to demonstrate substantial equivalence (SE).How to increase 510(k) submission quality.How to respond to FDA’s request of additional information.How to resolve different opinions between the submitter and FDA reviewer(s), if any.PASS-IT suggestions/recommendationsWho Will Benefit:Medical Device Quality and Compliance ProfessionalsPharmaceutical Compliance ProfessionalsQualityRegulatory AffairsCEOsVPsAttorneysClinical AffairsResearch & DevelopmentConsultantsContractors/SubcontractorsAnyone Interested in the 510(k) Matters

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Start: 2015-09-18T13:00:00-04:00

End: 2015-09-18T22:30:00-04:00

Tickets

Single Live : For One Participant 262.04 CAD 10

Single REC : For One Participant - Unlimited Access for 6 Months 314.54 CAD 5

Corporate Live : For Max. 10 Participants 940.92 CAD 5