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Zdrowie i gospodarka · 22/02/1999

Draft Guidance for Industry on Testing Orthopedic Implants With Metallic Plasma Sprayed Coatings to Support Reconsideration of Postmarket Surveillance Requirements; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry on Testing Orthopedic Implants With Metallic Plasma Sprayed Coatings to Support Reconsideration of Postmarket Surveillance Requirements.'' This draft guidance is neither final nor is it in effect at this time. Metallic plasma spray coatings, both porous and nonporous, and metallic sintered or diffusion bonded porous coatings are used to attach artificial joints to living bone. FDA's Center for Devices and Radiological Health (CDRH) is identifying a set of testing methods that will accurately compare the mechanical properties of metallic plasma spray coatings with the same properties of sintered or diffusion bonded porous coatings. This draft guidance document proposes to use a number of mechanical tests to compare the mechanical properties of the various types of coatings. CDRH needs the ability to make the above comparisons in order to identify coated hip devices that should be subject to postmarket surveillance requirements.

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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