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2019-11-26
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Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
84 FR 65162
https://www.govinfo.gov/app/details/FR-2019-11-26/2019-25631
2019-25631
fr26no19-68
4164-01-P
Docket No. FDA-2019-N-5465
https://www.govinfo.gov/app/details/FR-2019-11-26/2019-25631
https://www.govinfo.gov/content/pkg/FR-2019-11-26/html/2019-25631.htm
https://www.govinfo.gov/content/pkg/FR-2019-11-26/pdf/2019-25631.pdf
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84 FR 65162
Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program; Federal Register Vol. 84, Issue
NOTICE
2019-25631
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-N-5465
4164-01-P
2019-25631
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.
FDA is seeking participation in the voluntary EtO Pilot Program beginning November 26, 2019. See the ``Participation'' section for selection criteria for participation in the EtO Pilot Program and the ``Procedures'' section for instructions on how to submit a Master File for consideration for inclusion into the EtO Pilot Program. Up to nine eligible participants may be selected for the EtO Pilot Program.
Steven Elliott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4630, Silver Spring, MD 20993, 301-796-5285, Steven.Elliott@fda.hhs.gov.
Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program,
Steven.Elliott@fda.hhs.gov
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions
https://www.fda.gov/medical-devices/premarket-approval-pma/master-files
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-supplements-and-amendments
https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
https://www.regulations.gov
Federal Register
Vol. 84, no. 228
Office of the Federal Register, National Archives and Records Administration
2019-11-26
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