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Zdrowie i gospodarka · 5/20/2022

Medical Devices; 510(k) Sterility Change Master File Pilot Program

The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its 510(k) Sterility Change Master File Pilot Program ("510(k) Sterility Pilot Program"). The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single- use devices ("sterilization providers") using certain sterilization methods a pathway to submit a Master File for FDA's review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File and that satisfies other conditions outlined in this document. If a Master File is accepted into the 510(k) Sterility Pilot Program, manufacturers of 510(k)-cleared devices ("510(k) holders") may choose to reference the Master File in internal documentation in support of a justification for not submitting a new prema

Original source language: 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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