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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
21,672
cmeby
Discussions
C
UDI Questions on Control Units
Replies
6
Views
162
ChrisW
K
Relabeling an existing medical device in the field?
Replies
6
Views
132
cklau
Watchcat
FDA will not tolerate fraud…meaning what, exactly?
Replies
8
Views
747
Watchcat
R
Can I have 1 Medical Device with 3 different names?
2
Replies
15
Views
5,881
fialor
D
Private Label Distribution - US
Replies
1
Views
104
Cthames
P
UDI Registration - Class II Medical Device Software
2
Replies
10
Views
2,626
akp060
S
Where did FDA 510(K) form 3654 go?
Replies
4
Views
4,363
Madhubnvs
R
Is FCC required for Medical Equipment without Radio Frequency Energy?
Replies
6
Views
1,882
jdoran
P
AIM 7351731 RFID reader immunity
Replies
3
Views
700
Emily Tosio
J
Biocompatbility testing on Class 1 device requirements
2
Replies
12
Views
328
monoj mon
Watchcat
Summary of De Novo Biocompatibility Information, 2015-2018
Replies
0
Views
91
Watchcat
P
  • Poll
IDEs and Clinical Investigators - Advice About Records?
Replies
3
Views
115
pharm_dev
Q
Is Establishment Registration Necessary?
Replies
1
Views
102
indubioush
P
Component Traceability Requirements in a Class 2 Electronic Medical Device
Replies
5
Views
6,060
Sullen-gent
G
Voluntary Class I Device Filing
Replies
4
Views
146
gogreen
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