Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, Joe Pruitt, Carmen Gonzalez, Liz McMillan, Kevin Jackson

News Feed Item

FDA Director to Address the Final Guidance on Research and Investigational Use Only Devices

MEDIA ADVISORY

WASHINGTON, Feb. 25, 2014 /PRNewswire-USNewswire/ -- On February 26, AACC will host a webinar with Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health at FDA to discuss FDA's guidance on in vitro diagnostic products labeled for research use only (RUO) or investigational use only (IUO).

(Logo: http://photos.prnewswire.com/prnh/20130701/PH41045LOGO)

WHO: Dr. Gutierrez has been director of FDA's Office of In Vitro Diagnostics since 2009, and is a leading expert on regulating and ensuring the safety of medical tests.

WHEN: Wednesday, February 26
2–3 p.m.

WHERE: A Q&A With the FDA on the RUO/IUO Final Guidance

WHY: Labs are concerned about the impact that the guidance (Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff) will have on them.

With technology evolving rapidly in today's healthcare world, increasing numbers of clinical labs are using RUO/IUO products to conduct important medical tests. These products can have unproven performance characteristics. With its guidance on RUO/IUO, FDA seeks to protect patients from the negative health consequences that could arise if they are treated based on the results of such tests. While the guidance is directed toward manufacturers of RUO/IUO products who must ensure the labeling for their products is consistent with how they are supposed to be used, some think it may seriously impact the ability of clinical labs to serve patients. FDA understands that research and investigational use in vitro diagnostics need to be available for unique uses and claims this guidance will not disrupt the development of these products. However, many tests depend on instruments that are often labeled as RUO, and certain specialty tests for rare disorders would not be possible without RUO/IUO reagents. Furthermore, use of RUO/IUO products in the past has led to the development of cutting-edge diagnostic tests that have advanced patient care. During the AACC webinar, Dr. Gutierrez will discuss and answer questions about FDA's guidance on in vitro diagnostic products labeled RUO/IUO.

About AACC
Dedicated to achieving better health through laboratory medicine, the American Association for Clinical Chemistry (AACC) brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

SOURCE AACC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In this session we look at creating interactive communications via the web by adding messaging, file transfer, and group communication (group chat and audio/video conferencing) into the web experience. We will also discuss potential applications of this technology in areas including B2B, B2C, P2P, and gaming. Peter is Technical Director at Acision. He graduated from The University of Edinburgh in 2000 with a BSc (Hons) in Computer Science. After graduation Peter worked on a PSTN switch dev...
SYS-CON Events announced today the DevOps Foundation Certification Course, being held June ?, 2015, in conjunction with DevOps Summit and 16th Cloud Expo at the Javits Center in New York City, NY. This sixteen (16) hour course provides an introduction to DevOps – the cultural and professional movement that stresses communication, collaboration, integration and automation in order to improve the flow of work between software developers and IT operations professionals. Improved workflows will res...
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will mee...
SYS-CON Events announced today that Column Technologies, a global technology solutions company, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a leader in application performance and infrastructure management for commercial and federal markets. The company is headquartered in the United States, with a diverse and talented team of more than 350 employees around th...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that the DevOps Institute has been named “Association Sponsor” of SYS-CON's DevOps Summit, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. The DevOps Institute provides enterprise level training and certification. Working with thought leaders from the DevOps community, the IT Service Management field and the IT training market, the DevOps Institute is setting the standard in quality for DevOps education and training.
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Ras...
SYS-CON Events announced today that Blue Box has been named “Bronze Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Blue Box delivers Private Cloud as a Service (PCaaS) to a worldwide customer base. Built on a technology platform leveraging decades of operational expertise in cloud and distributed systems, Blue Box Cloud is a managed private cloud product available in both hosted and on-prem versions. Each Blue Box ...
SYS-CON Events announced today Sematext Group, Inc., a Brooklyn-based Performance Monitoring and Log Management solution provider, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting and anomaly detection (SPM), log management and analytics (Logsene), search analytics (S...
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Can call centers hang up the phones for good? Intuitive Solutions did. WebRTC enabled this contact center provider to eliminate antiquated telephony and desktop phone infrastructure with a pure web-based solution, allowing them to expand beyond brick-and-mortar confines to a home-based agent model. It also ensured scalability and better service for customers, including MUY! Companies, one of the country's largest franchise restaurant companies with 232 Pizza Hut locations. This is one example of...
GENBAND introduced its Real Time Communications (RTC) Client for Lync* to seamlessly combine real-time communications with Lync Instant Messaging (IM) and Presence. “We’re shaking up the economics of delivering Unified Communications (UC) and offering a compelling way to integrate previously bespoke communications technologies,” said Carl Baptiste, GENBAND’s Senior Vice President, Enterprise Solutions. “We’re offering enterprises the best of both worlds by combining our own high availability v...
SYS-CON Events announced today Arista Networks will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Arista Networks was founded to deliver software-driven cloud networking solutions for large data center and computing environments. Arista’s award-winning 10/40/100GbE switches redefine scalability, robustness, and price-performance, with over 3,000 customers and more than three million cloud networking ports depl...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
SYS-CON Events announced today that SoftLayer, an IBM company, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place June 9-11, 2015 at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place November 3–5, 2015 at the Santa Clara Convention Center in Santa Clara, CA. SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points...