The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued a spat of guidance documents this quarter. here are some of the more significant FDA regulations that were issued in the second quarter of 2014. Provided below are brief summaries of several guidance documents that affect manufacturers and marketers of medical devices.
The healthcare division reported revenue of $4.48 billion during the three months ended June 30, compared with $4.49 billion during the same three months in 2013. However, revenues increased from $726 million to $730 million.
While HIPAA was enacted to protect the protected health information of patients, it appears hospitals are incorrectly citing HIPAA as a protection of their own interests, argues Charles Ornstein, a ProPublica healthcare journalist, in a report co-published on NPR.
At the peak in 2006, according to a 2008 Government Accounting Office report, Medicare spent $14.1 billion on diagnostic imaging. Since then, annual spending has steadily dropped, falling by 21 percent by 2010, based on a Neiman Policy Institute report. To date, this trend has not reversed, Levin said. - See more at: http://www.diagnosticimaging.com/reimbursement/imaging-utilization-trends-and-reimbursement?GUID=52331DD9-6AF6-4DA6-9850-104DD469DEE5&rememberme=1&ts=25072014#sthash.MPKxXUgQ.dpuf
UL (Underwriters Laboratories) has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells).