Medical Device Clinical Study Requirements: New Changes Proposed by FDA for Foreign and US Studies
Webinar / Online
The medical device industry has recently seen a spike in companies conducting clinical studies outside the US (OUS) due to limitations in time, money, and other resources, combined with stringent FDA guidelines for US studies. However, FDA’s device regulations largely do not address or clarify requirements for assuring the acceptability of data from OUS studies to support US research or marketing applications. Additionally, there are inconsistencies in FDA’s device regulations regarding information to be provided about US clinical studies in different types of FDA applications. To address these issues and better harmonize regulatory expectations for clinical studies, whether conducted inside or outside the US, and whether used to support a FDA premarket approval application (PMA), premarket notification (510(k)), or investigational device exemption (IDE) submission, FDA recently issued a proposed rule -open for comment until May 28, 2013 – that would amend various parts of its device regulations. If finalized, these proposed amendments will significantly alter what companies must do to successfully use data generated abroad in support of FDA applications and submissions; it will also have new impacts for companies submitting US clinical data in support of FDA submissions.
(Courtesy of www.q1productions.com)
Q1 Productions: Medical Device Clinical Study Requirements: New ...
Wednesday May 15, 2013 - (12:00 PM-1:30 PM EST)
Online
Contact: Paul Hernandez: (phernandez@q1productions.com)
Phone: 312.602.9683
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