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FDA has published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug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.
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.
Lawrenceville, N.J.-based GS1 US was named the first accrediting issuing agency for unique device identifiers (UDIs) by the U.S. Food and Drug Administration, according to a news release.
The 3-D printing market for medical device applications is anticipated to grow 15.4 percent from 2013 to 2019, according to a Transparency Market Research report. In 2012, the market was valued at $354.4 million and is expected to reach $965.5 million in six years.
The latest iteration of the Bipartisan Budget Act of 2013 includes language that would strike down the 2.3% medical-device tax. The measure, which cleared the House last week, has been approved in the Senate and heads to President Barak Obama for his signature.