Medical Devices Today

Proposed Rule Defines Good Manufacturing Practices For Combo Products

Article preview reprinted from "The Gray Sheet" - September 28, 2009

FDA released its long-awaited proposed rule on good manufacturing practices for combination products Sept. 22. Read more...

Japan Rolls Out Three-Tiered Review System For Medical Devices

Full article reprinted from "The Gray Sheet" - September 21, 2009

Japan is rolling out a new three-track medical device review system based on the novelty of the product, Japanese device reviewers said last week. 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...

AHRQ, NIH Report To Congress On Comparative Effectiveness Spending Plans

Full article reprinted from "The Gray Sheet" - August 10, 2009

Two Health and Human Services agencies will allocate about $250 million this year in comparative effectiveness research funds from the federal stimulus package; the remainder of the $1.1 billion comparative effectiveness money will be put to use in 2010. Read more... 

510(k) Sponsors Should Be Wary Of Informal Talk With FDA, Attorney Says

Full article reprinted from "The Gray Sheet" - August 3, 2009

Informal communications via telephone or e-mail before or during a 510(k) submission can be an efficient approach for sponsors, but companies should be aware of the pitfalls, says Hogan & Hartson Partner and FDA device specialist John Smith. Read more...

AHRQ To Establish National Joint Replacement Registry

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

The Agency for Healthcare Research and Quality plans to spend $12 million over four years on a clinical registry of orthopedic devices, drugs and procedures. Find out more...

Unapproved Product Trial Data: To Post Or Not To Post On ClinicalTrials.gov?

Full article reprinted from "The Gray Sheet" - June 29, 2009

Device makers say new clinical trial registration and results reporting requirements should be extended to trials of unapproved products only if the trials were stopped for safety reasons. Read more...

FDA Expects Draft Document On Post-Approval Study Design By September

Full article reprinted from "The Gray Sheet" - June 29, 2009

FDA hopes to complete a draft scientific document on how to design post-approval studies for medical devices by September, according to Danica Marinac-Dabic, director of the Division of Epidemiology within CDRH's Office of Surveillance and Biometrics. Read More...

Greater FDA Transparency Could Benefit Industry, Too, Trade Reps Say

Full article reprinted from "The Gray Sheet" - June 29, 2009

Despite concerns with maintaining trade secret protections, industry has much to gain from increased openness by FDA, device industry representatives said at a June 24 meeting of FDA's new Transparency Task Force. Read more...

FDA Struggles To Create A User-Friendly Device Identification System

Full article reprinted from "The Gray Sheet" - June 22, 2009

The hardest part about establishing a mandatory unique identification system for devices is crafting one that all users - from manufacturers to distributors to hospitals - will be able to implement, FDA says. Read more...