Medical Devices Today

Increased CDRH Post-Approval Vigilance Plays Out In Medtronic X-Stop Trials

Medtronic clinical executive Ruchir Sehra says CDRH's newfound rigor in the postmarket area is evident in its approach to the firm's post-approval study of the X-Stop spinal implant.

"They seem to be encouraging more post-approval follow-up," said Sehra, VP-clinical and research of Medtronic's spinal and biologics business in Sunnyvale, Calif.

Sehra says the agency called for two post-approval follow-up studies on X-Stop, which received PMA approval in November 2005 ("¹The Gray Sheet" Nov. 28, 2005, p. 6). The implant offers a non-fusion option for alleviating the painful symptoms of lumbar spinal stenosis. Inserted between the spinous processes of symptomatic discs, it "distracts" the space around the nerves, preventing pinching.

OIG Allows Two More Gainsharing Programs; CMS Demos Still Pending

This article is reprinted from "The Gray Sheet" – January 21, 2008 Two more hospital/physician gainsharing programs focused on product standardization got the HHS Office of Inspector General's OK Jan. 14. "This now becomes the tenth opinion that we've secured in this area. It shows there is replication to the model," said Joane Goodroe, president of Goodroe Healthcare Solutions, which designed the projects. Gainsharing arrangements, whereby hospitals share with physicians the cost savings that come from quality and efficiency initiatives, are generally illegal, since physicians may be rewarded for reducing health services, or their referral patterns could be influenced. However, OIG has granted exceptions in certain cases, all designed by Goodroe, stating in the accompanying advisory opinions that it will not impose sanctions because the programs include enough patient protections.

FDA Aims To Establish Overseas Staff Posts, Starting In China

This article is reprinted from "The Gray Sheet" – January 14, 2008

FDA is considering posting staff overseas to perform inspections and foster relationships with foreign government counterparts and industry.

"There is a very real interest in pursuing this and obviously the spotlight has been on China ... but this is not just a China issue," FDA Deputy Commissioner for International and Special Programs Murray Lumpkin said during a Dec. 13 panel discussion on FDA's international issues hosted by the Food and Drug Law Institute.

"The products that we are responsible for within the United States are no longer domestic commodities," Lumpkin said.

"For the most part, whether it's on the food side of the house or the medical products side of the house, they are global commodities. They are discovered, developed, marketed, and most importantly they are used by consumers, practitioners and patients around the world."

"For Cause" Inspections Find Galloping Clinical Trial Violation Rate

This article is reprinted from "The Gray Sheet" – January 7, 2008

The violation rate for clinical trial sponsors shot up in fiscal year 2007, hitting a 10-year high, with FDA finding many of the problems during inspections triggered by complaints, according to CDRH.

Of the 40 trial sponsors inspected by the device center's division of bioresearch monitoring (BIMO) last year, 33% were classified by FDA as "official action indicated" (OAI), denoting that significant regulatory violations were found. That compares with 11% of the 53 sponsors inspected in fiscal 2006 that were significantly out of compliance, the best industry performance in 10 years.

Device companies were the target of eight BIMO warning letters in 2007, five more than in 2006.

The BIMO division is responsible for checking on the quality and integrity of clinical trial data, and ensuring that trial subjects are protected from undue hazards and risks. The unit oversees inspections of sponsors, clinical investigators, institutional review boards and bench testing labs.