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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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PubMed1998

Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.

The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medical devices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens.

Conservation of Natural Resources↗

PubMed1998

Administrative practices and procedures; internal review of decisions--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations governing the internal review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including human drugs, animal drugs, and human biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or advisory committee. This amendment implements the "Dispute Resolution" provision of the Food and Drug Administration Modernization Act (FDAMA). This document is intended to clarify that sponsors, applicants, or manufacturers of drugs, or devices may request review of scientific controversies by an appropriate scientific advisory panel or advisory committee.

Decision Making, Organizational↗

PubMed1998

Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.

The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.

Device Approval↗

PubMed1998

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

The Food and Drug Administration (FDA) is issuing final regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drugs, including biologics, and devices. The final rule describes the new use information that a manufacturer may disseminate and describes the content of and establishes procedures for a manufacturer's submission to FDA before it may begin disseminating information on the new use. The final rule also describes how manufacturers seeking to disseminate information on a new use must agree to submit a supplemental application 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 final rule provides for requests to extend the time period for submitting a supplemental application for a new use and describes how a manufacturer can seek an exemption from the requirement to submit a supplemental application for the new use. Additionally, the final rule discusses FDA actions in response to manufacturers' submissions, corrective actions that FDA may take or require, and recordkeeping and reporting requirements. The final rule implements sections 551 through 557 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa through 360aaa-6) as amended by section 401 of the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗

PubMed1998

Sacral nerve stimulation for the treatment of urge incontinence.

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Blue Cross Blue Shield Insurance Plans↗

PubMed1998

Financial disclosure by clinical investigators--FDA. Final rule; action on petition for reconsideration.

The Food and Drug Administration (FDA) is revising the requirements regarding financial disclosure by clinical investigators in order to add material to the codified language that was inadvertently omitted and to clarify the compliance dates to, in some cases, restrict the retroactive application of certain requirements of the rule. FDA is making these changes in order to respond to concerns raised by the Pharmaceutical Research Manufacturers Association (hereinafter referred to as "PhRMA"). By making these changes, FDA will be reducing the administrative burden for manufacturers and other affected parties while, at the same time, ensuring that the agency obtains the information that is most relevant to its review of clinical data submitted in marketing applications.

Clinical Trials as Topic↗

PubMed1999