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At least 811 records · Page 45Linked to original sources
PubMed1993

Medical devices; device tracking--FDA. Final rule; suspension of effective date; notification of status under the Safe Medical Devices Act; technical amendments.

The Food and Drug Administration (FDA) is announcing that it is suspending the effective date of the final rule on device tracking that appeared in the Federal Register of May 29, 1992, until August 29, 1993. The agency is also announcing that the revised proposed rule is now a final rule by operation of law. Further, the agency is amending the regulations to make certain technical amendments. This action is being taken to implement requirements of the Safe Medical Devices Act of 1990 (the SMDA) and the Medical Device Amendments of 1992 (the 1992 amendments).

Costs and Cost Analysis↗
PubMed1993

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.

Commerce↗
PubMed1996

Current good manufacturing practices for blood and blood components: notification of consignees receiving blood and blood components at increased risk for transmitting HIV infection--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma), Source Plasma and Source Leukocytes at increased risk for transmitting human immunodeficiency virus (HIV) infection have been collected. This final rule requires that when a donor who previously donated blood is tested on a later donation in accordance with the regulations and tests repeatedly reactive for antibody to HIV, the blood establishment shall perform more specific testing using a licensed test, if available, and notify consignees who received Whole Blood, blood components, Source Plasma or Source Leukocytes from prior collections so that appropriate action is taken. Blood establishments and consignees are required to quarantine previously collected Whole Blood, blood components, Source Plasma and Source Leukocytes from such donors, and if appropriate, notify transfusion recipients. The Health Care Financing Administration (HCFA) is also issuing a final rule, published elsewhere in this Federal Register, which requires all transfusion services subject to HCFA's conditions of Medicare participation for hospitals to notify transfusion recipients who have received Whole Blood or blood components from a donor whose subsequent donation test results are positive for antibody to HIV (hereinafter referred to as HCFA's final rule). FDA is requiring transfusion services that do not participate in Medicare and are, therefore, not subject to HCFA's final rule, to take steps to notify transfusion recipients. FDA is taking this action to help ensure the continued safety of the blood supply, and to help ensure that information is provided to consignees of Whole Blood, blood components, Source Plasma and Source Leukocytes and to recipients of Whole Blood and blood components from a donor whose subsequent donation tests positive for antibody to HIV.

Blood Banks↗
PubMed1997

Notification procedures for states implementing "alternative mechanisms" in the individual health insurance market--HCFA. Notice.

This notice generally describes the statutory provisions under section 111 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that guarantee availability of individual health insurance coverage to certain individuals with prior group coverage. It also provides procedural guidance for States that intend to implement an alternative mechanism under section 111 of HIPAA. Finally, this notice describes the statutory provisions that will apply in a State that does not implement an acceptable alternative mechanism. This notice does not establish new policy or requirements.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1992

Medical devices; device tracking--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.

Documentation↗
PubMed1998

New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations on notice of certification of invalidity or noninfringement of a patent to provide additional methods for new drug and abbreviated new drug applicants to provide notice to patent owners and new drug application (NDA) holders, without removing the existing means. These proposed amendments reflect current business practices and are intended to ensure that notice is provided to patent owners and NDA holders in a timely manner. FDA is also proposing to require certain applicants to submit to FDA a copy of the notice of certification.

Drug Approval↗
PubMed1998

Privacy Act of 1974; addition of routine uses to an existing system of records--HRSA. Notification of an addition of routine uses to an existing system of records.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing a proposal to add three new routine uses for the records in System of Records 09-15-0056, National Vaccine Injury Compensation Program (VICP), BHPr/ HRSA/HHS. HRSA proposes to specify the categories of records in the system, and to expand the list of routine use in record disclosures to include disclosures for research purposes, disclosures to annuity brokers, and disclosures to employees of life insurance companies for the purposes of providing benefits to recipients under the VICP.

Forms and Records Control↗