On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public meeting, where it will elicit comments from the public concerning the proposed changes to its 510(k) process. The meeting, which will be held next month, will focus primarily on the recommendations proposed in the recent report by the Institute of Medicine (IOM).
On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public workshop concerning its newly proposed regulation of mobile medical applications (“apps”). The meeting, which is scheduled for September 12, will focus on the emerging phenomenon of medical apps, defined as those applications used to diagnose or treat conditions.
On August 5, 2011, Joel Esquenazi and Carlos Rodriguez, former executives of Terra Telecommunications Corporation (Terra), were convicted by a federal jury on all counts for their roles in a scheme to pay bribes to Haitian government officials at Telecommunications D’Haiti S.A.M. (Haiti Teleco).
On Monday, August 1, 2011, the U.S. Court of Appeals for the Second Circuit overturned the 2008 convictions of four former executives of General Reinsurance Corporation (Gen Re) and one from American International Group (AIG). The Court’s opinion can be found here.
On July 27, 2011, Judge Mary Scriven of the United States District Court for the Middle District of Florida declared Florida’s Drug Abuse Prevention and Control law, § 893.13, Fla. Stat. as amended by § 893.101, Fla. Stat., unconstitutional. The Court found that the law violated due process because it eliminated mens rea as an element of felony delivery of a controlled substance thus making the law a strict liability offense. A copy of the opinion can be read here.
On August 2, 2011, the Financial Services Commission of the Florida Office of Financial Regulation issued a report to the Governor and his Cabinet regarding workers’ compensation fraud in the State of Florida. The report revealed that money services businesses have played an active, critical, and sometimes unknowing part in defrauding the workers’ compensation insurance market. Money Services Businesses are regulated by the Office of Financial Regulation pursuant to Chapter 560, Florida Statutes. A copy of the Office of Financial Regulation’s report can be read here.
A growing number of lawmakers, food-safety and consumer advocates are demanding that all lethal strains of Escherichia coli (E. coli) be declared adulterants when present in meat. There are seven known lethal strains of Shiga toxin-producing E. coli. Shiga toxin enters cells and stops the cells from producing proteins needed to function causing the cell to die. Symptoms include abdominal pain, bloody diarrhea, kidney failure and death.
Companies seeking to use health claims or nutrient content claims on food labeling must submit notification to the FDA prior to marketing. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), such claims must be based on current, published, authoritative statements from certain federal scientific bodies. On August 3, 2011, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that the Agency is seeking public comment concerning the collection of information associated with the submission of notifications of health claims or nutrient content claims.
On August 2, 2011, the U.S. Food and Drug Administration (FDA) published a notice for comment in the Federal Register regarding updated, withdrawn and modified standards for reviewing premarket applications for medical devices. The notice, entitled Modifications to the List of Recognized Standards, Recognition List Number: 027, is intended to “assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”
On August 1, 2011, the U.S. Food and Drug Administration (FDA) posted a notice for public comment regarding food safety fees associated with facility reinspections. The passage of the Food Safety Modernization Act (FSMA) earlier this year granted the FDA authority to impose and collect fees from food producers when the Agency has to reinspect the facility for compliance with FDA regulations. The Federal Register notice seeks to “obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business.” The FDA will accept comments until October 17, 2011.
