Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration (FDA) oversight.
The Colorado State University Spring Semester session will be starting in May 2014 regarding FDA 21 CFR 820 in the College of Biomedical Engineering. The title of the class is “FDA Quality System Regulation (21 CFR 820) and ISO 13485:2003 for Medical Devices” [EGLL 4094]. Lori Carr helped develop the material that will be presented during this ten (10) week session. Lori has taught this class during the Spring semesters of 2011, 2012, and 2013. She will assist with the 2014 session as her schedule permits. Please check the CSU website for specific information regarding this class or contact Deanna Scott at 970.402.5330 or e-mail her at [email protected] for more information.
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.
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 rulemaking process lacks transparency, efficiency
FDA has published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug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.