The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more
It is common for medical device makers to partner with doctors, universities, designers, manufacturers, R&D labs, or salespeople in the development of medical devices. To reap the intended benefits of such efforts,...more
The Medical Device Manufacturers Association (“MDMA”) has been vocal in lobbying Capitol Hill for what they consider “necessary changes” to patent law for continuing medical device innovation. Part of that lobbying has...more
4/30/2015
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USPTO
The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more
According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time. The Yale University Open Data Access (“YODA”)...more
Repeal of the medical device tax has seen frequent news coverage since the tax’s enactment in 2010 as part of the Affordable Care Act. The tax, which went into effect in January, 2013, imposes a 2.3% sales tax on a range of...more