AG/FDA Blog

FDA implements 21st Century Cures Act Requirements for Reusable Devices

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires… Read More
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FDA Implements 21st Century Cures Requirements for Devices

Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act).  The 21st Century Cures Act became law on December 13, 2016, and a… Read More
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OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition

On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas.  Forest Devices bested 41 other competitors hailing from some of t… Read More
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Medical Device “Top 5” for 2016

The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation i… Read More
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CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices

Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The propo… Read More
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FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share… Read More
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2015 In Retrospect

Happy New Year, readers!  Yet another year has come and gone.  I hope that 2015 was a good year for you, professionally and personally.  As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and… Read More
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Are You Ready for Electronic MDR Reporting?

Paper medical device reports (MDR) will soon be a thing of the past.  On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA e… Read More
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Device Firms: What You Should Know About The 21st Century Cures Act

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and C… Read More
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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Condu… Read More
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