Medical Devices Today

NICE To Seek Candidates For New-Tech Evaluation Program In First Half Of '10

Article reprinted from "The Gray Sheet" - December 21, 2009

Device and diagnostics companies should start thinking about products they would like to offer for evaluation under a new program in the U.K. Read more...

SEC, DoJ Beef Up Investigation Of Corporate Bribery And Corruption Overseas

Full article reprinted from "The Gray Sheet" - September 7, 2009

Device and pharmaceutical companies have been battered by government and congressional investigations of their domestic marketing practices. They now face increased scrutiny on another front as the Department of Justice and the Securities and Exchange Commission are stepping up their investigation of corporate corruption and bribery abroad. Read more...

Japan Makes Quick Progress On Device Reviewer Hiring Pledge

Full article reprinted from "The Gray Sheet" - July 13, 2009

Japan has already hired 12 of the 13 new device reviewers it pledged to add by year end, bringing its total to 47 as of April, according to a July 6 report. U.S. device industry reps are pleased. Find out more...

European Device Regs To Be Recast In 2010, With Separate IVD Revision

 Article reprinted from "The Gray Sheet" - June 1, 2009

The European Commission says it will move ahead with plans to overhaul the European Union's medical device regulatory framework next year, and hopes to impose a "modern set of rules" by 2015. Find out more...

European “Substances Of Very High Concern” List Published; Now What?

Full article reprinted from "The Gray Sheet" - November 17, 2008

U.S. device manufacturers are pushing for more guidance on ways to comply with new European requirements for devices containing chemicals classified as "substances of very high concern."

Levitronix Continues Testing On Recalled CentriMag Blood Pumping System

Full article reprinted from "The Gray Sheet" - August 11, 2008

Find out what Zurich-based Levitronix is doing with the help of the FDA to better understand the root cause of two adverse events that led to a Class I recall of its CentriMag extracorporeal blood pumping system, along with the CentriMag primary and back-up consoles.

EU Seeks Input On Device Regulation Revamp; Industry Says: ‘Too Soon’

Full article reprinted from "The Gray Sheet" - July 14, 2007

EU medical device regulation news: Find out why some in the device industry are pushing back against strong suggestions from the European government that it may move toward more aggressive, centralized oversight of medical devices.

To Avoid European Dawn Raids, Keep Competitive Practices Clean – Lawyers

Full article reprinted from "The Gray Sheet" - June 23, 2008

Find out why device companies operating in Europe should develop internal plans to avoid "dawn raids" by the European Commission or a national competition authority aimed at investigating potential anti-competitive practices.

European Commission Outlines Key Issues In Device Reprocessing Debate

Full article reprinted from "The Gray Sheet" - June 2, 2008

The European Union is taking its first steps towards determining whether to create a uniform policy on the reprocessing of medical devices labeled for single use.

At this early stage of the process, even the most basic issues - such as how to define reprocessing to distinguish it from refurbishing - are still up for discussion.

Some individual countries in Europe have single-use device (SUD) reprocessing laws, in some cases outlawing it and in others allowing it under regulatory oversight.

A regulatory approach in the U.S. has evolved during the past decade in which reprocessed devices are subject to risk-based pre-market review and post-market requirements, including validation of a reprocessor's sterilization and cleaning processes.

U.S.-China Device Talks Yield Some Concessions, But Big Issues Unresolved

This article is reprinted from "The Gray Sheet" – April 28, 2008

A recent meeting between U.S. and Chinese government officials and device industry reps yielded some concessions to opening up China's market, but left many more issues on the table, according to a U.S. industry participant.

"There are a number of outstanding regulatory concerns," said Nancy Travis, VP of global analysis and strategy for AdvaMed, in an interview.

Travis traveled to Guilin, China, the week of April 7 to participate in talks with staffers from the U.S. Department of Commerce and China's State Food and Drug Administration about issues impacting trade between the two nations. In addition to AdvaMed, the Medical Imaging Technology Association and the China Association for Medical Devices Industry represented device firms.

The talks were part of the U.S.-China Joint Commission on Commerce and Trade, a long-standing dialogue vehicle that includes a medical device task force. FDA often participates in the meetings, but did not attend this year.