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2018-02-16
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General Wellness: Policy for Low Risk Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
D09002ee1bdc35ae2
D09002ee1bdc35b5f
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``General Wellness: Policy for Low Risk Devices.'' FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This draft guidance is not final nor is it in effect at this time.
80 FR 2712
https://www.govinfo.gov/app/details/FR-2015-01-20/2015-00756
2015-00756
fr20ja15-54
4164-01-P
Docket No. FDA-2014-N-1039
https://www.govinfo.gov/app/details/FR-2015-01-20/2015-00756
https://www.govinfo.gov/content/pkg/FR-2015-01-20/html/2015-00756.htm
https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/2015-00756.pdf
3 p.
2712
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80 FR 2712
General Wellness: Policy for Low Risk Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-00756
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-N-1039
4164-01-P
2015-00756
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``General Wellness: Policy for Low Risk Devices.'' FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 20, 2015.
Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-796-8589.
Guidance:
General WellnessPolicy for Low Risk Devices
,
CDRH-Guidance@fda.hhs.gov
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 12
Office of the Federal Register, National Archives and Records Administration
2015-01-20
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daily
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230 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-01-20
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0042-1219
0364-1406
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000582072
f:fr20ja15
https://www.govinfo.gov/app/details/FR-2015-01-20
https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/FR-2015-01-20.pdf
https://www.govinfo.gov/content/pkg/FR-2015-01-20/xml/FR-2015-01-20.xml
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