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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Trump’s New OCR Director and HIPAA Policy

As federal policy rapidly develops under the Trump Administration, much of it reversing or seeking to reverse the Obama legacy, the world of medical privacy (at least that which is on the books for now) remains static – after all, privacy always ha… Read More
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FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulga… Read More
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What Will A Trump Administration Mean For The Medical Privacy Landscape?

With President-Elect Donald Trump’s unlikely victory in Tuesday’s election, we begin to look ahead at what the Trump Administration will mean from a medical privacy perspective.  Neither the media, nor Trump himself, made privacy, much less medi… 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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OSHA and FSMA (No, Not FDA This Time)

You thought FDA was the only agency implementing the Food Safety Modernization Act (FSMA), well think again.  The Occupational Safety and Health Administration (OSHA) promulgated a final rule that defines whistleblower protections for employees that… Read More
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CFSAN Changes Address

Today, the Food and Drug Administration (FDA) published in the Federal Register a final rule that amends relevant FDA regulations in Title 21 of the C.F.R. to change the address of the Center for Food Safety and Applied Nutrition (CFSAN).   81 Fed.… 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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FDA FSMA Final Rule – Mitigation Strategies to Protect Food Against Intentional Adulteration

The Food and Drug Administration (FDA) has published in the Federal Register a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34,165 (May 27, 2016), 21 C.F.R. Part 121 (Final Rule).  The proposed r… Read More
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