Trade Groups Urge FDA to Extend Compliance Period for eMDR Rule

The Advanced Medical Technology Association and other trade groups have called on the FDA to extend from one year to two years the period for complying with a proposed rule that would require device firms to electronically file adverse event reports with the agency.

DOJ Prosecutors Turn Attention to Manufacturing, Safety Issues

Recent cases suggest that the Department of Justice is increasingly pursuing cases related to device manufacturing, adverse event reporting and even product labeling. While the Food, Drug & Cosmetic Act does not have whistleblower provisions, Eugene Thirolf, director of DOJ’s Office of Consumer Litigation, has stated that he predicts that future qui tam cases will cite FDC Act violations, such as manufacturing controls or adverse event reporting issues, as evidence of fraud against the government in False Claims cases.

House Bill Would Let FDA Debar Device Researchers

The Strengthening of FDA Integrity Act, H.R. 3932, introduced by Rep. Joe Barton (R-TX), would grant the FDA authority to debar device clinical trial researchers convicted of felonies. The bill also would require the FDA to send annual debarment reports to Congress and would reduce the time it has to debar a researcher from five years to one.

Submitters Still Confused on Adverse Event Reporting to ClinicalTrials.gov

Device and drug firms that submit details about their clinical trials to ClinicalTrials.gov are still having problems reporting adverse events data, Deborah Zarin, the Web site’s director, told the FDA Risk Communication Advisory Committee on Nov. 12.

Third Parties Could Train Auditors for AP Inspection Program, AdvaMed Says

Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, has suggested that the FDA allow FDA-certified, third-party auditing firms train their own investigators.

Mark Mansour is a partner in the firm, Bryan Cave, LLP