Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained
NIST
The short answer: Standard weights, rigorous procedures, and state inspectors ensure measurements are fair and accurate

More Features

FDA Compliance News
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Michael Causey

FDA Compliance

FDA’s Shuren Works to Ensure Medical Device Industry Innovators

He hopes the Medical Device Innovation Consortium will help

Published: Wednesday, July 8, 2015 - 14:16

Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.

If potential users believe a product’s benefits outweigh its potential risks, Shuren said the agency is more likely to approve it today. “We want to make the U.S. a much more attractive market for medical device innovations,” he told attendees at this month’s Drug Information Association convention in Washington, D.C., acknowledging that the United States has some of the toughest standards blocking the way between device manufacture and approval.

Jeffrey E. Shuren, M.D., J.D., Director, CDRH
Jeffrey E. Shuren, director of the CDRH

Shuren pinned a lot of his hopes on the Medical Device Innovation Consortium (MDIC), the first public-private partnership devoted to the advancement of regulatory science in the medical device industry. MDIC aims to coordinate the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology. It will hold its annual meeting Sept. 25, 2015, in Washington, D.C.

Boasting 49 members, including large and small device companies, the Pharmaceutical Research and Manufacturers of America (PhRMA), venture capitalists, consumer groups, the FDA and National Institutes of Health (NIH), the Medical Device Innovation Consortium (MDIC) has been active during the past year or so, holding a slew of meetings across the United States (and Japan), spreading the good word of innovation.

Shuren also talked about the FDA’s May guidance, which offers additional detail regarding how it will consider patient needs as it weighs risk/benefit calculations. “We’re looking to find ways to reduce medical device time to market,” he says. CDRH is making “changes in our approach,” as evidenced by the guidance and the FDA’s work with MDIC, among other things, Shuren stressed.

First published June 18, 2015, on the AssurX blog.

Discuss

About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.