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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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FAQs
Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
Sam Lazzara
Oct 9, 2013
2
3
4
5
Replies
45
Views
21,672
Jun 16, 2015
cmeby
Discussions
C
UDI Questions on Control Units
ChrisW
Mar 19, 2021
Replies
6
Views
162
Friday at 8:12 AM
ChrisW
K
Relabeling an existing medical device in the field?
kchan
Apr 1, 2021
Replies
6
Views
132
Apr 4, 2021
cklau
FDA will not tolerate fraud…meaning what, exactly?
Watchcat
Jun 25, 2020
Replies
8
Views
747
Mar 28, 2021
Watchcat
R
Can I have 1 Medical Device with 3 different names?
Regulargirl
Aug 2, 2010
2
Replies
15
Views
5,881
Mar 25, 2021
fialor
D
Private Label Distribution - US
dr1vn
Mar 1, 2021
Replies
1
Views
104
Mar 24, 2021
Cthames
P
UDI Registration - Class II Medical Device Software
Peter So
Nov 21, 2016
2
Replies
10
Views
2,626
Mar 24, 2021
akp060
S
Where did FDA 510(K) form 3654 go?
SSchoepel
Apr 7, 2019
Replies
4
Views
4,363
Mar 24, 2021
Madhubnvs
R
Is FCC required for Medical Equipment without Radio Frequency Energy?
Roland chung
Mar 21, 2012
Replies
6
Views
1,882
Mar 15, 2021
jdoran
P
AIM 7351731 RFID reader immunity
phase90
Jan 29, 2020
Replies
3
Views
700
Mar 14, 2021
Emily Tosio
J
Biocompatbility testing on Class 1 device requirements
Janie
Feb 26, 2021
2
Replies
12
Views
328
Mar 2, 2021
monoj mon
Summary of De Novo Biocompatibility Information, 2015-2018
Watchcat
Mar 2, 2021
Replies
0
Views
91
Mar 2, 2021
Watchcat
P
Poll
IDEs and Clinical Investigators - Advice About Records?
pharm_dev
Feb 25, 2021
Replies
3
Views
115
Feb 28, 2021
pharm_dev
Q
Is Establishment Registration Necessary?
QualityPNW
Feb 25, 2021
Replies
1
Views
102
Feb 25, 2021
indubioush
P
Component Traceability Requirements in a Class 2 Electronic Medical Device
PBuckley
Mar 24, 2010
Replies
5
Views
6,060
Feb 24, 2021
Sullen-gent
G
Voluntary Class I Device Filing
gogreen
Feb 13, 2021
Replies
4
Views
146
Feb 17, 2021
gogreen
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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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