machinery/labeling

The U.S. Food & Drug Administration (FDA) is reviewing its labeling requirements for drugs, medical devices and biologics to ensure that health practitioners and patients are provided with what the agency believes is more thorough than what's currently provided.

The information summary, called Essential Prescribing Information, would be in a standardized format now under development. FDA's Center for Devices and Radiological Health is considering changes that would increase the amount of information medical device manufacturers would be required to include in their labeling. The Division of Cardiovascular, Respiratory, and Neurological Devices also has asked for comments on a draft labeling guidance that expands labeling requirements for products under its authority. The Health Industry Manufac-turers Association (HIMA) submitted comments questioning the need for new labeling requirements, claiming they would do little to enhance the safe and effective use of medical devices. FDA's labeling requirements are a huge issue within the medical industry, said HIMA spokesperson John Arnold. Many physicians and device manufacturers believe the requirements are overly restrictive and intrude on the practice of medicine.

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