The FDA is seeking comments on the possible role that a registry of breast cancer treatment using thermal ablation devices could have on advancing the development and standardization in use of thermal ablation devices. The ablation devices and therapies include cryoblation, focused ultrasound, interstitial laser, microwave, and radiofrequency ablation.

Under the Administrative Procedure Act (APA), when a governmental policy acts as a rule and alters existing regulation, the agency must first give the public "notice"--publishing the changes in the Federal Register, and allow the public to participate in policy-making by submitting written comments. This is known as the "notice and comment" rulemaking requirements. The FDA provides on its website instruction on how to comment on the proposed rules.

The FDA's interest focuses on the construction of breast cancer ablation feasibility trials, so that there is a 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 feels that having a registry for this treatment will lead to standardized protocols for pathology and imaging assessments for diagnosis and treatment of breast cancers. In addition, there would be centralized information about patient selection, devices, treatment settings and strategy, and other information. If practitioners use such registry, they would have the advantage of others' experiences in order fine-tune treatment. Uniformity in treatment would lead to a better understanding of imaging in treatment, safety and effectiveness. The registry might also lead to improved data management across the industry regarding thermal ablation devices and associated healthcare cost savings.

The Agency is asking for information and suggestions such as what registry information should be accessible by the public, healthcare providers, and professional organizations, and how the registry should be constructed. Written or electronic comments should be submitted by November 24, 2008.

See more at:
http://www.fda.gov/opacom/backgrounders/voice.html
http://www.fda.gov/OHRMS/DOCKETS/98fr/FR%20Doc%20E8-11899.htm

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