federal_register: 2019-25631
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-25631 | Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program | Notice | The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Ethylene Oxide Sterilization Master File Pilot Program ("EtO Pilot Program"). The EtO Pilot Program is voluntary and intends to allow companies ("sterilization providers") that sterilize single- use medical devices using fixed chamber ethylene oxide (EtO) to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, manufacturers ("PreMarket Application (PMA) holders") of Class III devices subject to premarket approval that are affected by such changes may, upon FDA's permission, reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a premarket approval application (PMA) supplement. The EtO Pilot Program seeks to help ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health while providing a regulatory approach that would address potential device shortages. | 2019-11-26 | 2019 | 11 | https://www.federalregister.gov/documents/2019/11/26/2019-25631/center-for-devices-and-radiological-health-ethylene-oxide-sterilization-master-file-pilot-program | https://www.govinfo.gov/content/pkg/FR-2019-11-26/pdf/2019-25631.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Ethylene Oxide Sterilization Master File Pilot Program ("EtO Pilot Program"). The EtO Pilot Program is voluntary and... |