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Results for “Device Approval”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 1,225 records · Page 68Linked to original sources
PubMed2005

The right fit.

Explore the source record for details and available documents.

Device Approval↗
PubMed2005

Medical devices; immunology and microbiology devices; classification of AFP-L3% immunological test systems. Final rule.

The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems 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: AFP-L3% Immunological Test Systems." 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 announcing the availability of a guidance document that will serve as the special control for the device.

Device Approval↗
PubMed2004

Successful recruitment for medical device clinical studies.

Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.

Clinical Trials as Topic↗
PubMed2004

When to conduct a clinical trial.

A clinical trial is designed to provide clinical evidence of compliance with the medical device Directives. Clinical evidence can also be based on systematic and objective literature review. This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device.

Clinical Trials as Topic↗
PubMed2004

The impact of the revised electromagnetic compatibility standard.

Electromedical equipment must be tested to the electromagnetic compatibility (EMC) standard EN 60601-1-2 to carry the CE mark. The new version of EN 60601-1-2, which becomes mandatory from 1 November 2004, could affect the design of some products. This article summarises the new EMC requirements and provides design tips on how to meet them.

Device Approval↗
PubMed2004

European medical device regulation: a new era?

By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understand and prepare for these policies.

Device Approval↗
PubMed2004

The US medical device bundling policy.

Companies preparing United States (US) premarket submissions should be aware of a US policy that may save them time and money. This policy allows the grouping or "bundling" of multiple devices or multiple indications for use in a single submission. This article discusses this policy and a US guidance document that explains when bundling is appropriate.

Device Approval↗
PubMed2005

Medical devices; immunology and microbiology devices; classification of cystic fibrosis transmembrane conductance regulator gene mutation detection system. Final rule.

The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems 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: CFTR Gene Mutation Detection Systems." 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 announcing the availability of the guidance document that will serve as the special control for the device.

Cystic Fibrosis↗
PubMed2005

Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule.

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner 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: Low Energy Ultrasound Wound Cleaner." 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, 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 the guidance document that will serve as the special control for the class II device.

Debridement↗
PubMedDate not supplied

FDA draft guidance on computerised systems used in clinical trials.

When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.

Clinical Trials as Topic↗