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Zdrowie i gospodarka · 3.08.1999

Medical Devices; Draft Guidance on Quality Systems Regulation Information for Various Premarket Submissions; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance on Quality System Regulation Information for Various PreMarket Submissions.'' This draft guidance is intended to assist medical device manufacturers with information they should include in premarket approval applications (PMA) and product development protocols (PDP) to demonstrate that the submissions are in compliance with the revised quality system (QS) regulation. This draft guidance document also describes the information that should be maintained at the manufacturing facility for premarket notifications (510(k)'s). This draft guidance document represents the agency's current thinking on the QS regulation information for various premarket submissions. This guidance is neither final nor is it in effect at this time. DATES: Written comments concerning this draft guidance must be submitted by November 1, 1999. ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. Submit written requests for single copies on a 3.5'' diskette of the draft guidance document entitled ``Draft Guidance on Quality System Regulation Inform

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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