Food and Drug Administration and Centers for Medicare & Medicaid Services

Websites:
http://www.fda.gov
http://www.cms.hhs.gov

The National Forum on Biomedical Imaging in Oncology (NFBIO) was created in 1999 to facilitate partnerships between researchers, the imaging industry, and government agencies. The goal is to address new biomedical opportunities and challenges in oncology and to focus on the regulatory, coverage, and reimbursement issues for established technologies to improve patient diagnosis and care. The forums are cosponsored by NCI, the National Electrical Manufacturers Association (NEMA), FDA, and CMS. The sixth NFBIO took place April 7–8, 2005, and focused on quantitative oncologic imaging. The speakers’ presentations and other information are available on the NFBIO Website: http://imaging.cancer.gov/NewsAndMeetings/meetings.

The Interagency Council on Biomedical Imaging in Oncology (ICBIO), with its next meeting set for October 17, 2006, brings representatives of NCI, FDA, and CMS together with technology developers to expedite the launch of new imaging products. \ The council’s representatives provide advice on the spectrum of scientific, regulatory, and reimbursement issues related to developing an imaging device or technology. Any business or academic investigator who develops a technology relevant to biomedical imaging in cancer may submit a request. Investigators typically meet with the council for approximately one hour for an informal and confidential discussion. More information is available on the council’s Website: http://imaging.cancer.gov/programsandresources/specializedinitiatives/ICBIO.

CIP and FDA have an interagency agreement to develop databases for evaluating image-processing methods for cancer screening, diagnosis, and treatment. The collaboration seeks to develop:

• Criteria to design and populate proposed image databases for the evaluation of computer-aided diagnosis and related processing methods
• Statistical methods to determine the size and content of the proposed image databases and permit the comparison of image processing or computer-aided diagnosis methods
• Statistical methodology for evaluating performance of computer-aided diagnosis and image-processing methods