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Results for “Device Approval”

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At least 811 records · Page 45Linked to original sources
PubMed1998

The limited state of technology assessment for medical devices: facing the issues.

Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical testing and regulation of medical devices, however, is vastly different from and inferior to the testing and regulation of drugs. As managed care organizations begin to exert controls on device use, providers are being caught between the policies of their organizations and the demands of device manufacturers and patients, who want wider access to devices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate information, and include the recently developed device assessment and reporting guidelines created by the Task Force on Technology Assessment of Medical Devices.

Device Approval↗
PubMed1998

Growth in the biomaterials market: the nature of growth factors.

An increasing number of medical devices are demonstrating better performance if they are used in association with growth factors. This is especially so in the area of tissue regeneration. This article describes the nature of these molecules and discusses some of the issues associated with their incorporation into medical devices.

Culture Techniques↗
PubMed1998

Clinical evaluation or investigation?

For devices undergoing clinical investigation in the European Union, manufacturers must comply with the requirements of the Medical Device Directive. In certain Member States, the Competent Authority reserves the right to perform a pre-assessment of clinical information together with a technical review of the proposed device. Inadequacies in these submissions remain the single most common reason for rejection.

Device Approval↗
PubMed1998

Medical devices; humanitarian use of devices--FDA. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule amending the regulations governing humanitarian use devices (HUD's). These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Altruism↗
PubMed1998

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

Chemistry, Clinical↗
PubMed1998

General hospital and personal use devices: proposed classification of liquid chemical sterilants and general purpose disinfectants--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to classify both liquid chemical sterilants intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use, and general purpose disinfectants intended to process noncritical medical devices and equipment surfaces. Under the proposal, liquid chemical sterilants would be classified into class II (special controls) and general purpose disinfectants would be classified into class I (general controls). FDA also proposes to exempt general purpose disinfectants from the premarket notification requirements. The agency is publishing in this document the recommendations of the General Hospital and Personal Use Devices Panel (the Panel) regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.

Device Approval↗
PubMed1998

Mutual recognition of pharmaceutical good manufacturing practice inspection reports, medical device quality system audit reports, and certain medical device product evaluation reports between the United States and the European Community--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its regulations pursuant to an international agreement between the United States and the European Community (EC). The agreement is entitled "Agreement on Mutual Recognition Between the United States and the European Community (MRA). Under the terms of the agreement, the importing country authority may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by the exporting authority determined by the importing authority to have an equivalent regulatory system. Likewise, the importing country authority may normally endorse medical device quality system evaluation reports and certain medical device product evaluation reports by conformity assessment bodies (CAB's) determined by the importing country authority to have equivalent assessment procedures. FDA is taking this action to enhance its ability to ensure the safety and effectiveness of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The proposed rule which published in the Federal Register on April 10, 1998 (63 FR 17744), carried an incorrect docket number in its heading. This final rule carries the correct docket number.

Device Approval↗
PubMed1998

Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken 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), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

Anesthesiology↗
PubMed1999

Regulatory aspects of ultrasound-assisted lipoplasty.

In our litigious medical environment, and particularly after the breast implant debacle, plastic surgeons must understand the regulatory implications of devices they implant in their patients. This article reviews the regulatory aspects of ultrasound-assisted lipoplasty and the regulatory fundamentals that apply to all new technology and devices.

Device Approval↗
PubMed1997

Bioabsorbable fixation devices: status for the craniomaxillofacial surgeon.

With time, more and more types of medical devices become available to assist the surgeon in managing patients. Bioabsorbable fixation devices, which have been directed toward the orthopedic surgeon over the past 10 years, are but one example. One aim of this article is to present the current status of bioabsorbable devices in medical practice to the craniomaxillofacial surgeon who may not be aware of the inroads this technology has made. A bioabsorbable fixation system has become available for use by the craniomaxillofacial surgeon, which is described. A further aim of this article is to present concisely the testing rigor required of such devices before their introduction to the U.S. market. This has the added benefit of explaining the important role of the surgeon in developing and helping reduce to standard clinical practice the use of new technologies.

Absorbable Implants↗
PubMed1998

Import for export; reporting and recordkeeping requirements for unapproved or violative products imported for further processing or incorporation and subsequent export--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing reporting and recordkeeping regulations to implement certain sections of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the FDA Export Reform and Enhancement Act of 1996. The proposed rule would require an importer to report to FDA each time it imports an unapproved or otherwise violative article that is to be exported after further processing or incorporation into another product in the United States and to keep records to ensure that the article is so processed or incorporated and then exported, and that any portion of the import that is not exported is destroyed.

Commerce↗
PubMed1998

FDA plan for statutory compliance. Notice of availability.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "FDA Plan for Statutory Compliance" (the plan). This document is the agency's response to section 406(b) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which requires the Secretary of the Department of Health and Human Services (the Secretary) to develop a plan bringing the agency into compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (the act).

Device Approval↗
PubMed1998

Medical devices; establishment registration and device listing for manufacturers and distributors of devices; correction--FDA. Direct final rule; correction.

The Food and Drug Administration (FDA) is correcting a direct final rule that appeared in the Federal Register of September 29, 1998 (63 FR 51825). The document amended certain regulations governing establishment registration and device listing by domestic distributors. The document was published with an error. This document corrects that error.

Device Approval↗
PubMed1998

Medical devices; establishment registration and device listing for manufacturers and distributors of devices; correction--FDA. Proposed rule; correction.

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 29, 1998 (63 FR 51874). The document proposed to amend certain regulation governing establishment registration and device listing by domestic distributors. The document was published with an error. This document corrects that error.

Device Approval↗