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APPENDIX F – FY 2003 OSEL Laboratory Tours

October 1, 2002 – September 20, 2003

OSEL began conducting tours of their research laboratories for CDRH managers in the spring of 2003. The tours have provided a major opportunity for OSEL to share its research activities and accomplishments with its colleagues throughout CDRH.

April 2003
The Division of Imaging and Applied Mathematics (formerly the Division of Electronics and Computer Science) sponsored a tour of its Medical Imaging and Computer Applications Branch Ultrasound Laboratory. The tour centered on ultrasound bone densitometry and how this technology fits into the CDRH/FDA regulatory mission.

May 2003
The Division of Chemistry and Materials Science (formerly the Division of Mechanics and Materials Science) sponsored a tour of their laboratories comprising three areas: compliance investigation, medical hydrogels, and estrogen disruption.

June 2003
The Electro-Optics Branch within the Division of Physics (formerly the Division of Physical Sciences) maintains a laboratory capability for evaluating the optical performance of intraocular Lenses (IOLs). IOLs are an evolving technology and new designs are continually being submitted to CDRH for pre-market approval. This tour offered a demonstration of ray trace analysis of an IOL in a model eye and air bench testing for the determination of power and resolution of IOL. Ray trace analysis can be used for a theoretical evaluation of the optical performance of IOL designs. The results of this analysis may be used to establish benchmarks for acceptance criteria.

July 2003
The Division of Biology (formerly the Division of Life Sciences) presented a discussion of the Interventional Device and Applied Cardiovascular Research Program. The performance of angioplasty balloons and stents are being evaluated in healthy and atherosclerotic vessels of swine. The research has demonstrated that gender, hormones, age and parameters such as device over-sizing and implant time play a significant role in the overall performance of these devices. Additionally, the safety and effectiveness of systemic versus local drug delivery on long-term performance is being determined. These studies analyze the safety and effectiveness of routes of administration (e.g., luminal vs abluminal) and the pharmacodynamics and pharmacokinetics of various drug therapeutics (e.g., estrogen, paclitaxel and rapamycin) to mitigate stenosis, restenosis and lesion development. The discussion took place during a preclinical study evaluating percutaneous coronary interventions in an atherosclerotic swine.

August 2003
The Medical Electronics Branch of the Division of Electronics and Software Engineering (formerly the Division of Electronics and Computer Science) conducted a laboratory tour to focus on recent and ongoing activities involving product realization. Product realization is the term used to embrace the engineering processes by which scientific advances are transformed into successful products that consistently perform as intended and satisfy user needs. This tour demonstrated how OSEL research, regulatory support, and outreach activities involving product realization contribute to CDRH's public health mission.

September 2003
There were no laboratory tours conducted this month.