Devices & Diagnostics Letter

An Oct. 1 CDRH reorganization brings radiological and mammography devices and in vitro diagnostics under a new Office of In Vitro Diagnostics and Radiological Health (OIR).

BOSTON — Companies preparing to comply with the Jan. 1, 2013, imposition of the medical device excise tax face significant stumbling blocks because the Internal Revenue Service (IRS) has yet to issue a final regulation on how the tax will be applied and is not expected to do so before the November elections, according to a panel of tax experts at the AdvaMed 2012 conference here.

BOSTON — Vision care company Bausch + Lomb found cataract lens development cycles significantly reduced after engineers started first examining the way lenses would work in the eye through 3-D computer modeling, a Bausch + Lomb official says.

BOSTON — Anti-fraud investigators may soon be taking a closer look at device clinical trials in an attempt to ensure that the safety and performance of devices reaching the market are supported by sound data, a government lawyer says.

During the coming year, the HHS Office of Inspector General (OIG) will continue examining the 510(k) premarket notification program and expects to release findings next year, the office says in its fiscal 2013 work plan.

The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting device safety concerns to Congress and the U.S. Office of Special Counsel (OSC).

Health Canada has expanded the scope of a pilot project that uses foreign drug reviews to aid in its assessment of new drug submissions to now include foreign reviews of Class III and IV devices.

BOSTON — Companion diagnostics that can be used to personalize medicine are no longer a pipe dream, but challenges to moving them to market remain, according to a Tuesday panel of experts at the AdvaMed 2012 conference.

Lax process and quality control of supplied components helped land Irving, Texas-based Epimed International an FDA warning letter.

BOSTON — Devicemakers need to make a more compelling value argument to the public if they want to secure favorable payment policy for innovative products, industry leaders said during “CEOs Unplugged” sessions at last week’s AdvaMed 2012 conference.