Regulatory Focus™ > News Articles > Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

Posted 23 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval despite being approved in Europe is an "affirmation of the US medical device approval process," reports The Star Tribune.

"The strongly worded document details what the FDA says are 12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale in Europe but not the United States," writes The Tribune. "It represents an FDA defense of its practices while industry groups, patient advocates and some in Congress propose changes in the way the agency does business."

The report, entitled Unsafe and Ineffective Devices Approved in the EU That Were Not Approved in the US, reportedly highlights numerous of cases in which European regulators allowed medical devices to be marketed despite FDA finding such devices to be lacking in evidence of either their safety or efficacy, reports The Tribune.

FDA's Center for Devices and Radiological Health (CDRH) Deputy Director William Maisel defended the report in remarks to The Tribune, saying the agency was "anticipating questions about the type of data we ask for."

"This is the evidence," added Maisel.

The report comes after a scathing attack by CDRH Director Jeffery Shuren against EMA in January 2012, in which Shuren described the European Medicine Agency's device approval standards as akin to treating EU patients "as guinea pigs."

The remark prompted European health officials to fire back at Shuren in a letter to FDA Commissioner Margaret Hamburg, reports Reuters.

Read more:

The Star Tribune - FDA rips Europe's system for medical device reviews

Reuters - WORLD EXCLUSIVE - 'Guinea pig' comment sparks US, EU device spat

Regulatory Focus - Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

Regulatory Focus newsletters

All the biggest regulatory news and happenings.