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Zdrowie i gospodarka · 31.08.1998

Global Harmonization Task Force: Draft Documents on Adverse Event and Vigilance Reporting of Medical Device Events; Availability

The Food and Drug Administration (FDA) is announcing the availability of five draft documents entitled ``Comparison of Device Adverse Report Systems'' (SG2-N6), ``Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices'' (SG2-N8), ``Global Medical Devices Vigilance Report (Form and Instructions)'' (SG2-N9), ``Pre' cis'' (Vigilance and Postmarket Surveillance) (SG2-N12), and ``Adverse Event Reporting Guidelines for Manufacturers'' (SG-N21). These documents have been prepared by members of the Global Harmonization Task Force (GHTF), study group 2 on Medical Devices Vigilance/Postmarket Surveillance Reporting Systems. The documents are intended to provide information only and represent a harmonized group of proposals. Elements of the approach set forth in these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.

Source: Federal Register — Food and Drug AdministrationOpen original release →
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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Crisis Response (PHCR) Cooperative Agreement. The Public Health Crisis Response (PHCR) Cooperative Agreement provides rapid funding to help existing public health programs respond to major public health emergencies and crises.

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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Respiratory Protective Devices--42 CFR 84. The purpose of this data collection is to enable 42 CFR part 84 respirator approval certification activities.

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Zdrowie i gospodarka · 9/28/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Emergency Preparedness (PHEP) Cooperative Agreement. This request proposes to collect information from the PHEP Cooperative Agreement awardees to document and monitor their performance measure progress and fulfillment.

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