SUMMARY: The Food and Drug Administration (FDA) is requesting comments on whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies (i.e. cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). FDA is specifically interested in understanding how breast cancer ablation feasibility trials can be constructed so that there exists standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens. The agency seeks to facilitate its understanding of local treatment for breast cancer using thermal ablation devices.
DATES: Submit written or electronic comments by November 24, 2008.
ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.regulations.gov.
To ensure timelier processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail.
FOR FURTHER INFORMATION CONTACT: Binita Ashar or Long Chen, Center for Devices and Radiological Health (HFZ-500), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3600, e-mail: binita.ashar@fda.hhs.gov or long.chen@fda.hhs.gov.
The complete documents could be viewed either at
FDA or ar
Regulations.gov.
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