Devices & Diagnostics Letter

The unsealing of a hence unknown 2009 qui tam (whistleblower) lawsuit filed against the FDA by seven former CDRH scientists embroiled in an ongoing email monitoring scandal may provide evidence the employees were sharing proprietary information, one legal expert says.

FDA officials sounded a familiar drumbeat during a Tuesday meeting on ways to notify the agency about changes to PMA products, asking devicemakers to submit more complete information upfront to ensure their submissions can be processed quickly.

Reforms in the FDA’s 510(k) procedures are needed to encourage risk-taking and speed the pace at which “substantially equivalent” devices are cleared for marketing, an industry expert says.

Devicemakers will have an opportunity to air their concerns about the FDA’s postmarket surveillance system at a Sept. 10 public meeting in Greenbelt, Md.

The FDA has given Lexington, Mass.-based GI Dynamics a conditional go-ahead to launch a pivotal clinical trial of its EndoBarrier for obese patients with Type 2 diabetes.

Medtronic’s neuromodulation unit has received an FDA warning letter on allegations the business segment did not handle complaints properly, among other corrective and preventive action (CAPA) violations.

Two former ArthroCare executives were arrested on fraud charges related to a U.S. Department of Justice (DoJ) investigation of a stock scheme aimed at defrauding company shareholders by announcing falsely inflated earnings.

Known for its relatively relaxed regulations on companion diagnostics (CDx), the European Medicines Agency (EMA) is not expected to provide guidance on the products until it has more experience in this area, an expert says.

Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event (SAE), according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.

Transparent partnerships with healthcare facilities and patient groups can help improve data collection during postapproval studies (PAS), a panel of experts said Thursday.