Other US Medical Device Regulations

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USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data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