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Results for “Device Approval”

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At least 1,099 records · Page 61Linked to original sources
PubMed2003

Medical devices; clinical chemistry and clinical toxicology devices; classification of the breath nitric oxide test system. Final rule.

The Food and Drug Administration (FDA) is classifying the breath nitric oxide test system into class II (special controls). 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). 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 announcing the availability of a guidance document that will serve as the special control for the device.

Breath Tests↗
PubMed2003

[Importance of the Therapeutic Products Act for the ENT practitioner].

The Therapeutic Products Act controls therapeutic products and their fields of application, and classifies them legally. The present regulations on therapeutic products are based on a fundamental concept comprising basic demands, harmonized standards, agreement of the product attributes with the basic demands, and assessment of conformity. Therapeutic products (among which in vitro diagnostics are counted) must comply with definite regulations and are separated from medicines by their mode of action. In addition, therapeutic products must be subject to critical testing. The establishment, management, and use of therapeutic products are, with few exceptions, governed by the Regulations for the Use of Therapeutic Products. To avoid possible risks involved in the application of therapeutic products, a well-functioning system of registration is required, controlled by the Regulations on Therapeutic Products Safety.

Device Approval↗
PubMed2003

Medical devices; obstetrical and gynecological devices; classification of the breast lesion documentation system. Final rule.

The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). 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.

Breast Neoplasms↗
PubMed2001

Current and future issues in sensitisation testing.

Sensitisation is one of the biological risks that needs to be addressed for any medical device before clearance or clinical evaluation. This article describes the state of the art for this evaluation and also new variants of the procedure to increase the accuracy of these tests, particularly when some metals, latex-based products and macromolecular proteins such as collagen are concerned.

Dermatitis, Contact↗
PubMed2001

An important step forward in the global harmonisation of premarket review programmes.

The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme that could have a significant effect on efforts to harmonise premarket review procedures worldwide. This article discusses the programme and the importance of submitting comments to FDA on this new initiative.

Animals↗
PubMed2003

Managing changes during a clinical investigation, Part I.

During the course of a clinical investigation, changes may need to be made to the device, the manufacturing process, the investigational plan or other aspects of the investigation. Part I of this article discusses the United States requirements for managing these types of changes. Part II will discuss European requirements and the need for developing a standard operating procedure to help ensure consistent compliance.

Clinical Trials as Topic↗
PubMed2003

Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule.

The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. FDA is taking this action 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 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Arrhythmias, Cardiac↗
PubMed2003

Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule.

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). 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 announcing the availability of a guidance document that will serve as the special control for the device.

Device Approval↗
PubMed2003

Medical devices; immunology and microbiology devices; classification of the endotoxin assay. Final rule.

The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). 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 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 (MDUFMA). 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 announcing the availability of a guidance document that will serve as the special control for the device.

Device Approval↗