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2018-01-13
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Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments
Notices
D09002ee1bdb96dd3
D09002ee1bdb96e6b
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 (FDA, the Agency, or we) is announcing the following public workshop entitled ``Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards.'' The purpose of the workshop is to present a draft design of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The workshop is intended to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope, a suitable framework and procedures, and requirements to facilitate implementation of an eventual pilot program. The overarching objectives of the ASCA pilot program are to streamline the standards conformity assessment of medical devices and to improve consistency and predictability in the premarket review process where certain FDA recognized standards are used.
83 FR 2165
https://www.govinfo.gov/app/details/FR-2018-01-16/2018-00551
2018-00551
fr16ja18-61
4164-01-P
Docket No. FDA-2017-N-6877
https://www.govinfo.gov/app/details/FR-2018-01-16/2018-00551
https://www.govinfo.gov/content/pkg/FR-2018-01-16/html/2018-00551.htm
https://www.govinfo.gov/content/pkg/FR-2018-01-16/pdf/2018-00551.pdf
3 p.
2165
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83 FR 2165
Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments; Federal Register Vol. 83, Issue
NOTICE
2018-00551
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-06-29
Docket No. FDA-2017-N-6877
4164-01-P
2018-00551
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards.'' The purpose of the workshop is to present a draft design of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The workshop is intended to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope, a suitable framework and procedures, and requirements to facilitate implementation of an eventual pilot program. The overarching objectives of the ASCA pilot program are to streamline the standards conformity assessment of medical devices and to improve consistency and predictability in the premarket review process where certain FDA recognized standards are used.
The public workshop will be held on May 22 and 23, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by June 29, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287, CDRHStandardsStaff@fda.hhs.gov.
Meetings:
Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop
,
CDRHStandardsStaff@fda.hhs.gov
Susan.Monahan@fda.hhs.gov
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
https://www.adobe.com/go/connectpro_overview
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.iso.org/standard/66912.html
https://www.iso.org/standard/67198.html
https://www.regulations.gov
Federal Register
Vol. 83, no. 10
Office of the Federal Register, National Archives and Records Administration
2018-01-16
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Table of Contents:
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AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-01-16
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0042-1219
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https://www.govinfo.gov/app/details/FR-2018-01-16
https://www.govinfo.gov/content/pkg/FR-2018-01-16/pdf/FR-2018-01-16.pdf
https://www.govinfo.gov/content/pkg/FR-2018-01-16/xml/FR-2018-01-16.xml
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