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Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
FAQs
Sam Lazzara
  • Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
2 3 4 5
Replies
45
Views
18,031
cmeby
Discussions
K
Unique Device Identifier for updates to legacy standalone software
Replies
1
Views
54
yodon
Marcelo Antunes
Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485
Replies
1
Views
456
blah01
R
Addressing training requirements - 21 CFR Part 820.25 (1) & (2)
Replies
2
Views
116
RCW
R
FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed
Replies
3
Views
156
REMV
Marc
FDA safety scandal: 50K hidden reports of heart device malfunctioning - May 2019
Replies
1
Views
105
Ronen E
M
How to Select FDA Medical Device Product Code?
Replies
3
Views
102
Ronen E
J
FDA Class 1 Medical Device UDI requirements
Replies
2
Views
160
jkc3usc
R
Medical Device Packaging Label Validation
Replies
8
Views
1,981
narkesteyn
Q
FDA 3500A Reports - Trip and Fall - Weight scale with a fold out platform
Replies
1
Views
98
Ronen E
R
  • Redirect
FDA News FDA's CDRH is silo-ing along product lines - Reorganization
Replies
–
Views
–
N/A
macchiato
Sale of Rx Only Medical Device to Physician Online
Replies
1
Views
106
Ronen E
R
FDA News FDA issues guidance on bench testing in premarket submissions
Replies
0
Views
75
Ronen E
C
Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring)
Replies
3
Views
931
melancholy
S
Creating a new commercial product based on a modification to an existing product
Replies
4
Views
239
shimonv
B
Manufacturing Company Address Change - implications for FDA
Replies
1
Views
146
drhkp
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