The Environmental Protection Agency reports that President Obama recently announced a historic agreement with thirteen major automakers to pursue the next phase in the Administration’s national vehicle program, increasing fuel economy to 54.5 miles per gallon for cars and light-duty trucks by Model Year 2025. The President was joined by Ford, GM, Chrysler, BMW, Honda, Hyundai, Jaguar/Land Rover, Kia, Mazda, Mitsubishi, Nissan, Toyota and Volvo -- which together account for over 90% of all vehicles sold in the U.S. -- as well as the United Auto Workers (UAW), and the State of California.
The Food and Drug Administration is requesting public comments on the Institute of Medicine’s report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” FDA is also planning a public meeting in the coming weeks to discuss recommendations made in the report. (In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must “clear” a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed “predicate” device.)
On August 1, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 027" (Recognition List Number: 027), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
On July 29, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is seeking comments by October 17, 2011 that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. The Agency is seeking public comment on what burdens these fees impose on small business, how small businesses should be defined, and whether and how the Agency should alleviate such burdens.
On July 27, 2011, the Environmental Protection Agency's ENERGY STAR program announced the top contenders at the midpoint of the 2011 National Building Competition, in which the building with the largest percentage reduction in energy use will be recognized as a winner in November 2011. The list of top contenders identifies 12 organizations with the greatest percent reduction of energy use. Of the 12 top contenders, there was one retail store, Office Depot, which had a 17% reduction in energy use.
The Food and Drug Administration has issued draft guidance that clarifies the kinds of changes or modifications to a previously cleared 510(k) device that trigger the need for a new premarket submission, such as changes regarding labeling, the technology used in the device, performance specifications, manufacturing changes, etc. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that a new or modified product is substantially equivalent to another legally marketed medical device. When manufacturers make changes or modifications to a device after FDA clearance that could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.
On July 27, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration's Office of Food Safety is seeking comments on proposed draft revisions to the "Principles for the Establishment and Application of Microbiological Criteria (MC) for Foods," which the working group of the Codex Committee on Food Hygiene is considering. Comments are due September 15, 2011. Copy of the proposed revision is available by emailing documents@brokerpower.com.