United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2019_register
executive
2019-09-14
article
Medical Devices; Exemption From Premarket Notification: Class II; Powered Wheeled Stretcher; Request for Comments
Notices
D09002ee1bdb6d0d9
D09002ee1bdb6d145
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
84 FR 48623
https://www.govinfo.gov/app/details/FR-2019-09-16/2019-19978
2019-19978
fr16se19-56
4164-01-P
Docket No. FDA-2019-P-3347
https://www.govinfo.gov/app/details/FR-2019-09-16/2019-19978
https://www.govinfo.gov/content/pkg/FR-2019-09-16/html/2019-19978.htm
https://www.govinfo.gov/content/pkg/FR-2019-09-16/pdf/2019-19978.pdf
3 p.
48623
48625
84 FR 48623
Medical Devices; Exemption From Premarket Notification: Class II; Powered Wheeled Stretcher; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-19978
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-11-15
Docket No. FDA-2019-P-3347
4164-01-P
2019-19978
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments by November 15, 2019.
Bryan Benesch, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-5506.
Medical Devices:
Exemption From Premarket Notification: Class II; Powered Wheeled Stretcher; Request for Comments
,
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 179
Office of the Federal Register, National Archives and Records Administration
2019-09-16
continuing
daily
deposited
born digital
242 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-09-16
P0b002ee1a2c05c4b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr16se19
https://www.govinfo.gov/app/details/FR-2019-09-16
https://www.govinfo.gov/content/pkg/FR-2019-09-16/pdf/FR-2019-09-16.pdf
https://www.govinfo.gov/content/pkg/FR-2019-09-16/xml/FR-2019-09-16.xml
fdlp
48547
48781
DGPO
2019-09-14
2023-04-28
FR-2019-09-16
machine generated
eng
FR
FR-2019-09-16
84
179