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2018-10-25
article
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Proposed Rules
D09002ee1bdba8e75
D09002ee1bdba8ed3
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) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
82 FR 51585
https://www.govinfo.gov/app/details/FR-2017-11-07/2017-24191
2017-24191
fr07no17-15
4164-01-P
Docket No. FDA-2017-N-6216
https://www.govinfo.gov/app/details/FR-2017-11-07/2017-24191
https://www.govinfo.gov/content/pkg/FR-2017-11-07/html/2017-24191.htm
https://www.govinfo.gov/content/pkg/FR-2017-11-07/pdf/2017-24191.pdf
Medical Devices
5 p.
51585
51589
82 FR 51585
Code of Federal Regulations
Title 21 Part 880
21 CFR Part 880
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device; Federal Register Vol. 82, Issue
PRORULE
2017-24191
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-01-08
Docket No. FDA-2017-N-6216
4164-01-P
2017-24191
Proposed order.
The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Submit either electronic or written comments on the proposed order by January 8, 2018. Please see section XI of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
Christopher K. Dugard, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240- 402-6031, christopher.dugard@fda.hhs.gov.
Medical Devices
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
,
christopher.dugard@fda.hhs.gov
https://www.accessdata.fda.gov/cdrh_docs/pdf/p960044.pdf
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070679.pdf
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073601.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 214
Office of the Federal Register, National Archives and Records Administration
2017-11-07
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daily
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213 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-11-07
P0b002ee19d7bcd78
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr07no17
https://www.govinfo.gov/app/details/FR-2017-11-07
https://www.govinfo.gov/content/pkg/FR-2017-11-07/pdf/FR-2017-11-07.pdf
https://www.govinfo.gov/content/pkg/FR-2017-11-07/xml/FR-2017-11-07.xml
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DGPO
2018-10-25
2023-04-28
FR-2017-11-07
machine generated
eng
FR
FR-2017-11-07
82
214