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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 6, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306030 |
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Title:
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New Medical Device? When Clinical Data Are Needed for a New Medical Device
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Author(s):
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Jeng Mah*+
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Companies:
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American Medical Systems Inc.
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Address:
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10700 Bren Road West, Minnetonka, MN, 55343,
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Keywords:
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decision rule ; loss ; Bayesian hypothesis testing ; clinical study
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Abstract:
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Medical devices are mechanical systems of hardware and software that deliver medical treatments. Compared to drugs, the design of a medical device can be modified gradually and often, the effects being more predictable. The physical nature of medical devices poses a challenge in determining applicability of safety and effectiveness data collected in predicate devices to a new device. In a regulatory setting, decisions about whether new studies are needed before allowing the marketing of new medical devices affect public well-being and the interest of the medical device industry. FDA has provided a guidance document outlining an "evidence model decision schematic," without an attempt to define "reasonable assurance" and "substantial equivalence" criteria for determining when clinical data are needed for new medical devices.
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