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Results for “Device Approval”

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At least 1,261 records · Page 70Linked to original sources
PubMed2006

Medical devices; exception from general requirements for informed consent. Interim final rule.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

Device Approval↗
PubMed2006

[Exploration on the regulation mode of medical device quality and safety on a life-circle basis].

A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.

Device Approval↗
PubMedDate not supplied

The nurse's role in contributing to new device development.

Nurses are in an ideal position to use their clinical observations to highlight unmet needs in relation to device use. This paper explores issues that relate to medical devices. An overview is given of the medical device field and examples are given from a survey of the healthcare literature to determine the level of user involvement in device development.

Clinical Competence↗
PubMed2006

Medical devices; immunology and microbiology devices; classification of fecal calprotectin immunological test systems. Final rule.

The Food and Drug Administration (FDA) is classifying fecal calprotectin immunological test systems into class II (special controls). The special control that will apply to these devices is the guidance document entitled, "Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems." The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.

Device Approval↗
PubMed2006

Accommodative intraocular lenses for age-related cataracts.

The standard intraocular lens (IOL) that is used to replace a cataractous lens cannot change focus from distant to near objects, so most patients need glasses for near vision after cataract surgery. Limited evidence suggests that accommodative IOLs provide better near vision than monofocal IOLs, but not better than multifocal IOLs. Long-term follow-up is needed to confirm patient outcomes, and determine whether the benefits justify the additional cost.

Accommodation, Ocular↗