postmarket

In addition, opponents say that the influx of new money from the user fees has gone largely to the premarket approval process at the peril of other areas -- such as postmarket approval.

MedPageToday.com - medical news plus CME for physicians 2010

The Justice Department alleges Medtronic caused false claims to be submitted to Medicare and Medicaid by using two postmarket studies and two device registries as the vehicle to pay participating physicians illegal kickbacks.

Medtronic to Pay $23.5 Million to Settle Kickback Allegations Nathalie Tadena 2011

And the Food and Drug Administration retreated from plans to tighten rules on medical-device approvals, postponing a proposal that would have given the FDA power to order additional postmarket studies of devices.

U.S. Backs Down on Work Noise, Medical Devices Alicia Mundy 2011

The companies have said they would cooperate with additional postmarket studies of mesh products but have argued they shouldn't have to undergo a premarket approval process.

Surgical Mesh Gets Closer Look Jennifer Corbett Dooren 2012

The panel also agreed with FDA plans to seek postmarket studies of existing products.

FDA Panel Calls for Surgical Mesh Studies Jennifer Corbett Dooren 2011

Also last week, the Food and Drug Administration retreated from plans to tighten rules on medical-device approvals, postponing a proposal that would have given the FDA power to order additional postmarket studies of devices.

Labor Department Withdraws Recordkeeping Proposal Melanie Trottman 2011

Medtronic Inc. has agreed to pay $23.5 million to resolve allegations that it paid illegal kickbacks to physicians who participated in its postmarket studies and device registries to induce doctors to implant the company's pacemakers and defibrillators, the Department of Justice said Monday.

Medtronic to Pay $23.5 Million to Settle Kickback Allegations Nathalie Tadena 2011

The companies have asked the FDA to keep the products as Class II, but said they agreed with the need to conduct postmarket clinical studies and design training programs for surgeons who use the devices.

FDA Panel Calls for Surgical Mesh Studies Jennifer Corbett Dooren 2011

On Friday, Medtronic said it had started enrolling patients in a postmarket study outside the U.S. for its CoreValve device.

Abbott Heart Device Gains Jonathan D. Rockoff 2010

On Friday, Medtronic said it had started enrolling patients in a postmarket study outside the U.S. for its CoreValve device.

Abbott Heart Device Gains Jonathan D. Rockoff 2010