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2017-06-09
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Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications
Notices
D09002ee1bdbc1a34
D09002ee1bdbc1a88
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 or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.
82 FR 26807
https://www.govinfo.gov/app/details/FR-2017-06-09/2017-12007
2017-12007
fr09jn17-42
4164-01-P
Docket No. FDA-2017-N-2901
https://www.govinfo.gov/app/details/FR-2017-06-09/2017-12007
https://www.govinfo.gov/content/pkg/FR-2017-06-09/html/2017-12007.htm
https://www.govinfo.gov/content/pkg/FR-2017-06-09/pdf/2017-12007.pdf
4 p.
26807
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82 FR 26807
Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications; Federal Register Vol. 82, Issue
NOTICE
2017-12007
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-08-08
Docket No. FDA-2017-N-2901
4164-01-P
2017-12007
Notice.
The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.
These actions are effective on August 8, 2017.
Constance Soves, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1437, Silver Spring, MD 20993-0002, 301- 796-6951.
Medical Devices:
Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications
,
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf
https://www.congress.gov/114/bills/hr34/BILLS-114hr34eah.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 110
Office of the Federal Register, National Archives and Records Administration
2017-06-09
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113 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-06-09
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2017-06-09
https://www.govinfo.gov/content/pkg/FR-2017-06-09/pdf/FR-2017-06-09.pdf
https://www.govinfo.gov/content/pkg/FR-2017-06-09/xml/FR-2017-06-09.xml
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FR-2017-06-09
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FR-2017-06-09
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