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

6 years ago Posted By : User Ref No: WURUR24627 0
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  • Location Aurora, Colorado, United States
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  • Date 13-09-2018
Understanding the FDA’s revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), Aurora, Colorado, United States
Webinar Title
Understanding the FDA’s revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Event Type
Webinar
Webinar Date
13-09-2018
Last Date for Applying
13-09-2018
Location
Aurora, Colorado, United States
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Health care
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Business Development

Economics

Biotechnology

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

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)
    • Guidance overview
    • Acceptance review timing
    • Five preliminary questions
    • Checklist review
  • Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s
    • Guidance overview
    • Grounds for refusing to accept an application
    • Combination product administrative items
    • 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]

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Tel: +1-720-996-1616

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Others Details

Get in-depth knowledge about Refuse to Accept Policy for 510(k)s and Premarket Approval (PMA) acceptance process. The webinar helps concerned individuals understand how to prevent a refuse to accept situation

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months. $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
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  Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016  Pin/Zip Code : 80016-6104
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Training Doyens

Training Doyens 26468 E Walker Dr,Aurora, Colorado

[email protected]

   +1-720-996-1616