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Results for “Device Approval”

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At least 775 records · Page 43Linked to original sources
PubMed1998

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. 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). FDA is publishing these amendments in accordance with its direct final rule procedures. 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 a significant adverse comment and withdraws this direct final rule.

Device Approval↗
PubMed1998

Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to issue new regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drug, including biologics, and devices. The proposal, which would implement the dissemination provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), would describe the content of and establish procedures for a manufacturer's submissions to FDA before it may begin disseminating information on the new use. The proposal also would describe how manufacturers seeking to disseminate new use information must agree to submit a supplement for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The proposal also would provide for requests to extend the time period for submitting a supplement for a new use, and it would describe how a manufacturer can seek an exemption from the requirement to submit a supplement. Additionally, the proposal would discuss FDA actions in response to manufacturer's submissions, corrective actions that FDA may take, and recordkeeping and reporting requirements.

Device Approval↗
PubMed1998

Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

Animals↗
PubMed1998

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

The Food and Drug Administration (FDA) is amending its 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. This action is being taken to clarify the availability of review of scientific controversies by such advisory panels and committees. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule. If any significant adverse comment is received, FDA will withdraw the direct final rule and will follow its usual procedures for notice-and-comment rulemaking based on the companion proposed rule.

Decision Making, Organizational↗
PubMed1998

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

The Food and Drug Administration (FDA) is proposing to amend the 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 agency is taking this action to clarify the availability of review of scientific controversies by such advisory panels or committees. This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice and comment rulemaking based on this proposed rule.

Decision Making, Organizational↗
PubMed1998

Guidance of FDA's expectations of medical device manufacturers concerning the year 2000 date problem--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem." The guidance, which is included in this notice, is a Level 1 guidance that is immediately effective in accordance with FDA's good guidance practices (GGP's) criteria, which allow immediate implementation of guidance that is necessary for public health reasons. FDA will receive comments on the guidance at any time and consider them in determining whether to amend the current guidance.

Chronology as Topic↗
PubMed1998

Financial disclosure by clinical investigators; correction--FDA. Final rule; correction.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 2, 1998 (63 FR 5233). The document issued regulations requiring the sponsor of any drug, including a biological product, or device marketing application (applicant), to submit certain information covering the compensation to, and financial interests of, any clinical investigator conducting certain clinical studies. The document was published with an error. This document corrects that error.

Conflict of Interest↗
PubMed1998

Medical devices; retention of three preamendment class III devices in class III--FDA. Final rule.

The Food and Drug Administration (FDA) is retaining the following three preamendments class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency is taking this action because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury.

Device Approval↗
PubMed1998

Memorandum of understanding between the Food and Drug Administration and the Defense Alliance for Advanced Medical Terminology--FDA. Notice.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Defense Alliance for Advanced Medical Terminology (DAAMT). The purpose of the MOU is to enable government agencies to exchange information and jointly pursue research endeavors related to medical device safety and effectiveness.

Device Approval↗
PubMed1998

Public information; communications with state and foreign government officials--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations governing communications with State and foreign government officials. The proposed rule would permit FDA to disclose confidential commercial information to international organizations having responsibility to facilitate global or regional harmonization of standards and requirements. These disclosures would, in almost all instances, occur only with the consent of the person providing the confidential commercial information to FDA. The proposed rule would also streamline the process for FDA officials to disclose certain nonpublic, predecisional documents (such as draft rules and guidance documents) to State and foreign government officials. The proposal does not alter current procedures for sharing documents that contain confidential commercial information. These changes are intended to facilitate information exchanges with State and foreign governments and certain international organizations.

Device Approval↗
PubMed1998

Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal.

The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

Device Approval↗
PubMed1998

Medical devices; reports of corrections and removals--FDA. Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. The 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). FDA is publishing these amendments in accordance with its direct final rule procedures. 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; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The 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). This companion proposed rule is issued under FDAMA and the act as amended.

Device Approval↗
PubMed1998

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal.

The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

Device Approval↗