Lori A Carr

Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations for medical devices and pharmaceutical products.

Two individuals on 13 FEB 2014 were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration.  The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.

The desk of cardiologist Yoav Dori at the Children’s Hospital of Philadelphia is scattered with small, odd-looking rubbery blobs.  “We made them so they fit together like Lego,” he says, connecting them one-by-one like a puzzle.  But this isn’t playtime.  It’s an accurate model of his 3-year-old patient’s heart, which has needed surgical repair since birth.

FDA rulemaking process lacks transparency, efficiency

The FDA takes an average of 7.3 years to finalize rules that determine its regulation process, a study published in the February issue of Health Affairs found.  Rules associated with cost-benefit analyses take the longest to review, and longer review times often mean the final rules are less stringent than the ones proposed initially.

FDA has published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight.  The agency was accepting public comments on the guidance through April 2014.

The Department of Health Research (DHR) will set up a Medical Technology Assessment Board (MTAB) to evaluate all kinds of existing and new medical technologies, in line with the recommendation of the Planning Commission working group for the current Five Year Plan.

Congress has agreed to spare from sequestration about $85 million in user fees paid by life science companies to the Food and Drug Administration (FDA), according to U.S. Rep. Leonard Lance.

 The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typical communications between agency reviewers and medical device applicants between submission and final clearance.

Parks Associates predicts unit sales of networked medical devices will exceed 14 million units by 2018, more than five times the sales from 2012, according to a new report. The firm also looked at what connected medical devices consumers had in their homes.