FDA 510(k) Update: Trends, New Strategy, Submission and FDA Clearance
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Category Biotechnology , Healthcare , Medical Device , Pharmaceutical
Deadline: July 15, 2015 | Date: July 15, 2015
Venue/Country: Online, U.S.A
Updated: 2015-06-30 16:27:06 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis webinar is intended to discuss recent 510(k) trends, new strategy, submission and FDA clearance. . The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance. At the end of this webinar, you will become better aware of the FDA 510(k) contents for submission including dos and don’ts. As a result, you will be able to develop your own practical, actionable and sustainable approaches for your successful 510(k) submission and clearance. Why should you attend :This webinar is intended to provide you with how to best put a compelling 510(k) package for submission including Dos and Don’ts. Areas Covered in the Session:Statute(S) And Regulations Including Recent Amendments.DefinitionsMedical Device Classification Including IVDs510(k) ProcessSelecting Predicate Device(s)De Novo Process ? Practical AdviceHow To Demonstrate Substantial Equivalence510(K) Contents And Format510(k) Preparation: Dos and Don’tsAddressing Technical And Regulatory Requirements510(k) Submission Quality For A Product-Be AwareResponding to FDA’s Request Of Additional Information.Resolving Different Opinions Between The Submitter And FDA Reviewer(S).Avoiding Common Mistakes with Awareness510(k) TrendsBest PracticesSpeaker’s PASS-IT RecommendationsWho will benefit: (Titles)Regulatory Affairs Managers, Directors and VPsClinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)R&D Scientists, Engineers, Managers, Directors, and VPsQuality Engineers, Managers, Directors, and VPsCompliance Officers and Legal CounselComplaint Handling and Risk Management Managers and DirectorsClinical investigators and CRO EmployeesConsultantsSenior and Executive ManagementAnyone Interested in the 510(k) SubmissionWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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