Devices & Diagnostics Letter

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that certain high-risk medical devices undergo more rigorous premarket scrutiny akin to that required by the FDA.

Gut instincts can play a crucial role in telling devicemakers what they need to know in selecting suppliers, an FDA official says.

FDA enforcement of unique device identifier (UDI) requirements will likely be delayed to allow for ample implementation time, but unwritten mandates in the draft rule with the potential to snarl inspections require prompt attention, compliance experts and former agency officials say.

An analysis of data from a pivotal trial of Stryker’s Wingspan Stent that was aborted due to a high stroke rate failed to find a single “smoking gun” behind the adverse events and likely won’t lead to a reconsideration of the FDA’s recent use restrictions, one expert says.

The Senate passed a fiscal 2013 spending extension Sept. 22 that would keep the federal government and FDA funded at current levels through March 27.

A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could bump a majority of current Class A IVDs into Class B.

The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, a CDRH official says.

The FDA handed Atlanta-based CardioMEMS a warning letter for numerous deviations related to a clinical investigation and PMA for its CardioMEMS HF Pressure Measurement System.

CINCINNATI ­— To help the FDA meet new congressional mandates and complex globalization challenges, devicemakers need to shed their fear of reporting supply chain concerns and manufacturing flubs, agency officials say.

India’s medtech industry is expected to grow by more than 15 percent annually as the country’s middle class and insurance coverage begin to ramp up, according to a PricewaterhouseCoopers (PWC) survey of Indian medical device companies.

Companies developing in vitro diagnostic (IVD) tests for Lyme disease should include randomized sampling from at least three geographically distinct U.S. locations in their 510(k) submission to the FDA, an agency official says.

Reports of a 24 percent increase in recalls caused by medtech software may not accurately reflect the scope of the problem or what it means for suppliers, an expert says.