FDA Commissioner Hamburg has recently created a new FDA enforcement directorate, the Office of Global Regulatory Operations and Policy, under Deb Autor.  The goal is to strengthen FDA oversight and enforcement of global supplier controls regardless of whether the product in question is a medical device, diagnostic equipment, drug, biologic, or nutritional supplement.

Hundreds of cyber-security geeks watched recently as Jay Radcliffe stood on a Las Vegas stage and hacked into his own insulin pump, disabling its life-saving therapy. The 33-year-old cyber-security researcher said the pump had "pretty much no security on it" - a vulnerability it shares with pacemakers, implantable heart defibrillators and other medical devices.

Here's some good news in the wake of dire economic reports and wild sways in the stock market: U.S. venture capital investment in the life sciences, which includes Minnesota's signature medical device industry, surged 37 percent in the second quarter, according to a report released earlier this month.
    

The Food and Drug Administration (FDA) recently announced the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2012.

For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices.

It's the August doldrums and everyone, even the president, seems to have fled the capital for a late summer vacation. But some policymakers press on: The FDA announced an important user-fee deal with generic drugmakers that would require them to pay fees like Big Pharma.