Search PubMed⌕ Search

PubMed · 15303561

Effective risk management programmes.

Abstract

Far too many medical device companies are failing to reap the benefits of an effective risk management programme. Thus, patients, users and the companies themselves are continuing to suffer the consequences of device problems that could have been identified and resolved before products are placed on the market. This article discusses how to implement an effective programme.

Explore related subjects

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Maria Donawa. 2004. Effective risk management programmes.. https://pubmed.ncbi.nlm.nih.gov/15303561/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

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↗

Medical devices; immunology and microbiology devices; classification of reagents for detection of specific novel influenza A viruses. Final rule.

The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, "Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses" and limitations of distribution of these reagents. 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 Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the 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 a special control for this device.

Device Approval↗