Devices & Diagnostics Letter

Congressional lawmakers say the FDA is holding up their investigation into reports the agency monitored the personal emails of employees who voiced product safety concerns to Congress, noting that almost five months have gone by without an agency response to a request for key documents.

Medical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.

A report of an exposed conductor in a St. Jude defibrillator lead has renewed questions about the safety of some of the company’s cardiac products.

Edwards’ Sapien transcatheter heart valve appears poised for broader use after an FDA panel voted in favor of approving a PMA that would expand the device’s indication to a select group of high-risk heart patients.

The Juvenile Diabetes Research Foundation (JDRF) and Helmsley Charitable Trust have pledged millions of dollars toward research by Medtronic and Becton Dickinson (BD) on improved glucose monitoring technology, in an effort to bring artificial pancreases to market faster.

To smoothly transition clinical investigation oversight from one institutional review board to another, devicemakers, contract research organizations (CRO), new and old IRBs and clinical investigators should work closely to minimize disruptions to the ongoing trial and ensure subjects are constantly protected, according to an FDA draft guidance.

An FDA inspection of Salt Lake City-based BioMeridian International found 16 observations — most in the form of missing procedures or documentation.

The FDA should be cautious before entering into agreements via the Innovation Pathway that foster device development at research and academic centers, industry insiders urge.

An experimental technique for producing medical imaging isotopes without a nuclear reactor could help stanch a worldwide shortage of technetium-99m (Tc-99m), researchers at the University of Alberta, Canada, say.

Medical devicemakers, drug companies and some local government officials are urging Health Canada to expand its Summary Basis of Decision (SBD) initiative so product approval reports are published more quickly and on a wider range of products.

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs unnecessarily without any benefit to patient safety, industry groups maintain.