The FDA wants input from the health care industry and the public on the efficacy of its medical device labeling system.
The federal watchdog agency is opening up a 60-day public comment period, slated to end Jan 3, 2012, on the med-tech labeling system.
"The purpose of this study is to determine the most effective device labeling format and inform FDA’s regulatory approach on standardized device labeling," according to the FDA. "Findings will provide evidence to inform FDA’s regulatory approach to standardizing medical device labeling across the United States."
The federal watchdog agency plans to ask health care providers how easy it is to follow instructions on medical devices, how organized the information is and how useful they find it.
The FDA also announced a public workshop on medical device use in pediatrics in Silver Spring, Md., Dec 5, hoping for some insight on the use of scientific research data to support and establish pediatric indications for medical devices.
The federal watchdog agency’s medical device review and approval process has been getting some flak from lawmakers recently.
House Republicans introduced 10 bills aimed at the FDA’s medical device review and approval process.
The bills, sent to the Energy & Commerce Committee this week, detailed proposed measures to reform the predictability, consistency and transparency of the federal watchdog agency’s med-tech review process.