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What are the European requirements for managing changes that may occur during a clinical investigation? Part II of this article discusses these requirements and the development of a standard operating procedure to help ensure consistent compliance.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
The Given M2A(R) ingestible, disposable imaging capsule contains a miniature video camera, which, when it is swallowed, can transmit images to a computer. It is used to detect abnormalities in the inner lining of the small intestine. In studies of small numbers of patients, the capsule demonstrates superior diagnostic rates for disorders of the small intestine among adults and children. All studies report fewer complications or less patient discomfort with the use of the capsule. Limiting factors are the time taken by physicians to evaluate the images, the lack of comparative evaluations of the capsule's sensitivity and specificity compared to conventional procedures and the impact of its cost.
Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of global harmonisation. This article discusses the programme and why European manufacturers should consider participating.
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With an innovative industry and an active market, Israel is at the forefront of medical technology. The country follows international standards wherever possible and is a favourable location for clinical trials.
The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device.
The iBOT 3000 Mobility System allows users to move around at an elevated height. The system uses the I-Balance Technology to actively maintain stability by driving the wheels to stay under the user.
In less than nine months, manufacturers of medical devices containing certain types of tissues of animal origin will need to ensure that their products comply with newly mandated specifications. They should not wait until the last minute to begin this work. This article discusses the important issues that will need to be addressed to ensure effective compliance with the requirements.
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The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
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Endoscope-based products for the treatment of more severe forms of gastroesophageal reflux disease provide an alternative to the use of drugs or surgery. Results from case series have shown that selected patients benefit through relief of symptoms and reduction of medication. Reported adverse effects appear to be minor. Efficacy has been mostly assessed over short periods and there is little information on comparison with other treatments. Procedural skills and appropriate training in their use are required. These technologies are promising, but their place in health care is not established.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.