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Adverse Event Reporting To Be Scrutinized By HHS Inspector General In FY ’06

This article was originally published in The Gray Sheet

Executive Summary

The HHS Office of the Inspector General intends to evaluate device manufacturer and user facility compliance with mandatory adverse event reporting requirements

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CED lives: "I would like to stop the rumor that CED is dead," said Steve Phurrough, MD, director of CMS' Coverage & Analysis Group May 3 at AdvaMed's Medicare policy meeting in Baltimore. "We've had some issues develop" with the draft policy for coverage-with-evidence-development, in particular with the Office for Human Research Protections and patient privacy regulations, he said. Such issues led to "false starts" in the National Oncologic PET registry, which under a January 2005 national coverage decision requires patients to enroll in a registry so they can get certain cancer-monitoring scans (1"The Gray Sheet" March 20, 2006, p. 9). But most issues have been resolved over the last several months, said Phurrough, and the PET registry is scheduled to open May 8. CMS plans to release a second draft guidance document to address and ask for comments on those concerns in the near future...

FDA Will Customize Foreign Facility Inspections To Improve Efficiency

FDA inspectors will take a more customized approach to auditing foreign device manufacturing facilities in 2006 to improve the efficiency of costly overseas trips, device center Office of Compliance Director Tim Ulatowski suggests

FDA Will Customize Foreign Facility Inspections To Improve Efficiency

FDA inspectors will take a more customized approach to auditing foreign device manufacturing facilities in 2006 to improve the efficiency of costly overseas trips, device center Office of Compliance Director Tim Ulatowski suggests

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