This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years. The new guidance that have resulted from “Refusal-to-Accept” and Electronic Submissions of Medical Device applications will also be presented.
Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. As part of receiving such fees, the FDA makes commitments to the industry with regards to certain performance goals with regards to review and approval processes and timelines.
The Medical Device User Fee Amendments of 2012, or MDUFA III took effect on October 1, 2012 and will sunset in five years on October 1, 2017. During that time, the processes for interacting with the FDA will be updated, impacting the way a medical device manufacturer does business with the FDA.
Change is inevitable; Suffering is optional!!! This is the best way to describe the Medical Device User Fee Act III that, among other things, changes the way that the FDA accepts submissions for Medical Devices. This will cause significant changes in how Medical Device Companies need to handle 510(k) and PMA submissions between the years 2012-2017.
This webinar will include review of the changes the FDA is making in accepting Medical Device Submissions and will propose solutions to some of the problems that will result from those changes. The goal of the webinar is to reduce / eliminate suffering from these changes, by discussing the strategies required to move forward with minimal disruption to the business.
Areas Covered in the Session :
How the FDA got from MDUFA I to MDUFA III
New Law: FDA Safety & Innovation Act (FDASIA)
Process & Policy Improvements
Updated Quantitative Goals
MDUFA III Review Times
Elimination of Exemptions for Registration Fees
Electronic Copy Provision
Implementation of MDUFA III
Required MIII Guidance
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Clinical Trial Physician / Doctor
Manager to Senior Director of
Institutional Review Board
Single Live : For One Participant
Corporate Live : For Max. 10 Participants
Single REC : For One Participant - Unlimited Access for 6 Months