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Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

“Food Fraud Database”: a New Tool to Protect Against Tainted Ingredients

Last week, the U.S. Pharmacopeial Convention (“USP”), a scientific nonprofit that sets standards for food ingredients, medicines and dietary supplements enforceable by the Food and Drug Administration, released an updated...more

FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act

On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Supreme Court To Examine Generic Drug Lawsuits

The U.S. Supreme Court will hear arguments next year on whether lawsuits against defective generic drugs can proceed in state court if they are not in violation of federal law. In Mutual Pharmaceutical Co v. Bartlett,...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Announces 100k Genome Project

The Food and Drug Administration(FDA) and the Centers for Disease Control (CDC) are collaborating with the University of California Davis and Agilent Technologies, a chemical analysis/engineering company from Santa Clara,...more

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more

California Publishes New Draft of Informal Green Chemistry Regulations

Yesterday the California Department of Toxic Substances Control (DTSC) convened a Green Ribbon Science Panel (GRSP) to continue work on the state's Green Chemistry initiative. Readers may recall from previous posts that...more

Governor Brown Signs Two Bills Intended to Protect Children From Toxic Exposures

In an effort to protect children (and, to a lesser extent, adults) from toxic exposure, California has banned the use of the controversial chemical Bisphenol A (BPA) in baby bottles and sippy cups, and has eliminated certain...more

FDA Releases New Strategic Plan for Regulatory Science

This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new...more

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more

Electronic Medical Records

You may never need to fill out a form when you visit a doctor's office. Instead of having a different medical record number at each hospital or doctor's office, patients can have their entire medical history accessible online...more

California Issues New Green Chemistry Requirements for Consumer Products

In a highly anticipated new development, California’s Department of Toxic Substances Control (“DTSC”) submitted its Green Chemistry Proposed Regulation for Safer Consumer Products to the state Office of Administrative Law...more

Letter to Washington Governor Re Water Fluoridation

The fluoridation materials used to fluoridated drinking water are not tested or approved by any federal or state agency. Fluoridation materials are added to drinking water for health reasons - to prevent tooth decay, and so...more

Letter to Washington Governor Re Lead Problems with Water Fluoridation

The silicofluorides typically used to fluoridate water contain lead, leach lead from pipes and solder, and facilitate lead uptake by the human body. The Safe Drinking Water Act requires disclosure to the public regarding lead...more

McCaffrey v. Apple and AT&T

Class Action Complaint (iPhone 4)

Class Action Complaint accusing Apple and AT&T of knowingly distributing a phone with a malfunctioning antenna. Apple (maker of iPhone 4)and AT&T are accused of numerous infractions. The Complaint asserts causes of...more

Batteries for Portable DVD/MP3/CD Players Recalled

As we all continue to move towards a world where technology envelops ever more of our daily lives, we encounter new products that offer the utmost in convenience and capabilities. Many people have believed in the benefits of...more

Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices

On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the...more

Greening of Consumer Products - December 1, 2008

IN THIS ISSUE: *Federal ban on pthalates won't apply to goods already in warehouses or on store shelves *Software tracks new REACH list of substances *Green chemical companies work toward sustainable solutions *FDA...more

Greening of Consumer Products - May 28, 2008

IN THIS ISSUE: *Wal-Mart spent $2.2 million lobbying consumer product safety legislation *California seeking input on its green chemistry initiative *Canadian government begins process to ban everyday...more

Greening of Consumer Products - May 14, 2008

IN THIS ISSUE: *New bills push for better regulations on toxic products sold in California *Connecticut moves to limit lead in children's toys *Climate Counts' second annual company scorecard finds food services industry...more