AG/FDA Blog

FSMA Update: FDA Releases FSMA Compliance Deadlines Guide

FDA has released a helpful and user friendly Food Safety Modernization Act (FSMA) compliance date webpage to assist farmers, manufacturers of food and food products, and other stakeholders.[1]  The webpage includes deadlines for the following rules:… Read More
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FDA Report on Food Code Adoption

As manufacturers of food products, it is significant to understand the food safety regulations for retailers and the food service industry, such as restaurants and grocery stores, and institutions, such as nursing homes. On October 4, 2017, FDA relea… Read More
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Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months

Last Thursday, at the Politico Policy Summit, Commissioner Scott Gottlieb announced that the new Nutrition Facts requirements compliance date will be pushed back one-year and, subsequently, announced via Twitter that the compliance date extension wil… Read More
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FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s c… Read More
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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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