The Center for Devices and Radiological Health (CDRH) has requested $384,815,000, an increase of $16,473,000, in the fiscal year 2011 budget, according to the U.S. Food and Drug Administration.
Highlights of the funding request include:
• an initiative to create a national strategy for the use of health-related electronic data that incorporates unique device identifiers.
• the purchase of data and hiring of an epidemiologist to start to create the infrastructure to analyze pediatric postmarket device information. The agency will broaden the scope of targeted surveillance of pediatric device use and performance.
• the Medical Device Safety initiative, which will help CDRH to ensure safety of products shipped to the United States. This program will allow the agency to hire five staff for an audit program of foreign government inspections and to increase foreign and domestic medical device inspections.
• support for the development of standards for safe CT scanners and fluoroscopes and a pilot dose registry program. Additionally, an education program on medical imaging dose awareness will be implemented.
• inspection expansions starting at the end of fiscal year 2014. Funding will add inspection capacity, improve data collection and risk analysis for medical product and enhance the postmarket safety assessment.
• hiring of those with advanced knowledge in computer science, software engineering and networked systems in order to increase CDRH's ability to evaluate device systems that integrate "smart" devices.
• increasing laboratory and product testing capacity, scientific staff development and training.
Click here to see the complete budget request.