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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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Regulations for Selling Convenience Kit vs. Selling Separate Parts
Sandman2002
May 20, 2014
Replies
2
Views
2K
Jun 1, 2014
MIREGMGR
M
N
Accelerated Aging Test for Disposable Protective Garment for Incontinence
Nixica
May 19, 2014
Replies
1
Views
2K
May 20, 2014
planB
L
New Website from the FDA concerning UDI Exceptions, Alternatives and Time Extensions
lfrost
May 16, 2014
Replies
0
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2K
May 16, 2014
lfrost
L
G
Need help on Device Description in the Acceptance Checklist for Traditional 510(k)
gerhardr
May 10, 2014
Replies
2
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2K
May 13, 2014
gerhardr
G
J
Change in wording, but not content - Special 510k?
JB0828
May 12, 2014
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2
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2K
May 12, 2014
JB0828
J
I
FDA eCopy Guidance for Comments
isoalchemist
Oct 22, 2012
Replies
5
Views
3K
May 6, 2014
lynchoid
L
S
What are the differences between Traditional 510(k) and a PMA to meet 21 CFR 814.20 ?
Sue789
Apr 21, 2014
Replies
3
Views
2K
Apr 22, 2014
SuperGirl
S
J
Safety and Efficacy study for a medical device in US
Jennifer27
Apr 19, 2014
Replies
5
Views
2K
Apr 20, 2014
Jennifer27
J
B
FDA - New Establishment Registration and Device Listing Requirements
bblbbblb
Oct 31, 2012
2
Replies
14
Views
8K
Apr 14, 2014
MIREGMGR
M
C
Is the firmware in a component OTS if it is customised?
CPTrillian
Apr 9, 2014
Replies
2
Views
2K
Apr 11, 2014
maaquilino
M
510(k) "received date" discrepancy
marmotte
Apr 9, 2014
Replies
1
Views
2K
Apr 9, 2014
MIREGMGR
M
R
Policy Statement for FDA CFR 820 Acceptance Activities of Incoming Products.
riverine68
Mar 26, 2014
Replies
1
Views
2K
Mar 28, 2014
Stijloor
Doctor owned Medical Device Company Investigation
Wes Bucey
Mar 11, 2014
Replies
1
Views
2K
Mar 11, 2014
MIREGMGR
M
ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI)
Ajit Basrur
Feb 18, 2014
Replies
1
Views
2K
Feb 26, 2014
Stijloor
Y
Labeling requirements for X-ray detector
youuu
Feb 25, 2014
Replies
1
Views
2K
Feb 25, 2014
MIREGMGR
M
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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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