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Results for “Device Approval”

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At least 793 records · Page 44Linked to original sources
PubMed1996

Purchasing silicone.

Now that CE-marking of medical devices is in force, device manufacturers need to be able to document that they employ the correct materials and components for a particular application. To do this they need to understand exactly what they are purchasing and show that their suppliers possess the necessary product range, technical expertise, and, most importantly, the quality procedures required to assure product integrity. This article sets out some basic definitions of terminology relating to material specification and testing of silicone products.

Device Approval↗
PubMed1998

Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal.

The Food and Drug Administration (FDA) published in the Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to implement the new Dispute Resolution provision of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

Decision Making, Organizational↗
PubMed1998

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction.

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.

Decision Making, Organizational↗
PubMed1998

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

The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

Device Approval↗
PubMed1998

Medical devices; establishment registration and device listing for manufacturers and distributors of devices; companion to direct final rule--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing establishment registration and device listing by domestic distributors. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.

Device Approval↗
PubMed1998

FDA Modernization Act of 1997: modifications to the list of recognized standards; availability; withdrawal of draft guidance "Use of IEC 60601 standards; medical electrical equipment"--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the publication of the modifications to the list of standards that will be recognized for use in the premarket review process and withdrawing its draft guidance entitled "Use of IEC 60601 Standards; Medical Electrical Equipment." This will assist manufacturers who elect to declare conformity with consensus standards to meet all or part of medical device review requirements.

Device Approval↗
PubMed1998

Technology assessment of medical devices at the Center for Devices and Radiological Health.

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

Device Approval↗