Understanding the FDA' revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Date : 13th September 2018 to 13th September 2018

Place : United States, Aurora

Website :https://bit.ly/2vNfHkG

Contact Person:Training Doyens

Description:

OVERVIEW In early 2018, the US FDA updated its Premarket Approval (PMA) acceptance process and Refuse to Accept policy for 510(k) submissions. The primary issues that these documents seek to rectify is the number of incomplete and/or inadequate PMAs that are submitted each year and it is the intent of the FDA going forward that they will no longer accept submissions that do not meet their standard of acceptability. This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special. The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time. The Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) contains other critically important checklists that cover the acceptance review criteria for PMAs. This document also addresses medical device products which include drug components. The guidance outlines new requirements direct registrants to include drug patent information as well as any exclusive marketing rights that may cover a combination product’s drug component. The FDA requires this information as a factor in determining whether applications are complete and can proceed to more in-depth reviews. WHY SHOULD YOU ATTEND It is critical, for those involved in the preparation of 510 (k)s and PMAs that the submissions be flawlessly prepared to prevent a refuse to accept situation. Understanding these guidance documents and applying the standards discussed will significantly mitigate the possibility of a refuse to accept letter from being received. AREAS COVERED • FDA refuse to accept policy for 510 (k) o Guidance overview o Acceptance review timing o Five preliminary questions o Checklist review • Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s o Guidance overview o Grounds for refusing to accept an application o Combination product administrative items o Checklist LEARNING OBJECTIVES • List and describe the contents of the Refuse to accept 510 (k) and Acceptance and Filing Reviews for Premarket Approval Applications Guidance Documents • Identify the critical components of each Guidance Document • List and describe the five preliminary questions that are identified in the Refuse to Accept for 510 (k) document • List and describe the contents application of the checklists contained in each guidance document WHO WILL BENEFIT This webinar has been designed for professionals in the medical device field and who require an update as to the provisions of the new guidance documents that have been issued. These professionals includeRegulatory affairs, Quality assurance, Clinical research, and Data management and monitoring. For more detail please click on this below link: https://bit.ly/2nDxHtw Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Understanding the FDA' revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) will be held in Aurora,United States on date 2018-09-13

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Deadline for abstracts/proposals : 13th September 2018

Keynote Speakers : Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.

Venue :Training Doyens, East Walker Drive, Aurora, CO, USA

Check the event website for more details.