AG/FDA Blog

FDA Announces Medical Device Quality System Regulation Change

FDA recently announced a potential massive overhaul to its Medical Device regulations.  Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consens… Read More
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FDA Finalizes Nutrition Facts Compliance Date Extension by 1.5 Years

On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rul… Read More
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FDA Denies Use of Claim for Vitamin D Reducing MS Risk

Last week, the FDA concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of multiple sclerosis (MS). The petition, submitted on behalf of Bayer, requested use of the claim “Vitamin D may reduc… Read More
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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Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance).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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