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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
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USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data
bio_subbu
Apr 23, 2015
Replies
1
Views
2K
May 2, 2015
Stijloor
R
Wellness Device Labeling Guidelines and question
RAbsurd
Apr 30, 2015
Replies
2
Views
2K
May 1, 2015
RAbsurd
R
Regulatory Plan / Strategy Template?
pbojsen
May 4, 2010
2
Replies
10
Views
30K
Apr 29, 2015
pseudoazurin
P
R
Finding specific 510k guidance for Keratoprosthesis (MLP)
RobertvanBoxtel
Apr 29, 2015
Replies
1
Views
1K
Apr 29, 2015
MIREGMGR
M
S
Anyone know the self-selection study for home use medical device
sunshineshu
Apr 22, 2015
Replies
2
Views
2K
Apr 22, 2015
isoalchemist
I
J
Change of contact person
Jennifer27
Apr 16, 2015
Replies
3
Views
2K
Apr 17, 2015
Jennifer27
J
I
FDA Marketing Claims - What is and isn't allowed
image182
Apr 2, 2015
Replies
3
Views
3K
Apr 14, 2015
image182
I
P
What are these Medical Device Company entities?
pecuniadelictumest
Apr 9, 2015
Replies
5
Views
1K
Apr 10, 2015
MIREGMGR
M
Importing medical device for use in fit testing of packaging
ScottK
Apr 10, 2015
Replies
3
Views
2K
Apr 10, 2015
ManTheDan88
M
R
Working on a 510(k) that is very similar to the predicate device
robertjbeck
Mar 29, 2015
Replies
4
Views
2K
Mar 29, 2015
robertjbeck
R
Q
FDA - Annual Report Submission Format and QMS updates
QAengineer13
Mar 24, 2015
Replies
2
Views
4K
Mar 24, 2015
QAengineer13
Q
J
Clinical Testing - NSR Device
Jennifer27
Mar 19, 2015
Replies
2
Views
2K
Mar 20, 2015
davishont02
D
Y
New Draft FDA Guidance for Applicability of GLP in Medical Device Submission
yana prus
Aug 28, 2013
Replies
2
Views
3K
Mar 19, 2015
Ronen E
M
Does anyone have a breakup of Establishments based on Device Classes ?
Mark Meer
Mar 17, 2015
Replies
1
Views
2K
Mar 19, 2015
Stijloor
M
Help interpreting 21 CFR Part 806 (corrections and removals)
Mark Meer
Mar 17, 2015
Replies
1
Views
2K
Mar 17, 2015
somashekar
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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