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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
25,260
Jun 16, 2015
cmeby
Discussions
M
CBE (Change Being Effected) 510(k) Submission
monoj mon
Sep 2, 2019
Replies
8
Views
3,513
Mar 10, 2023
EmiliaBedelia
J
ASTM F965 Laryngoscopes
jawad shahid
Mar 7, 2023
Replies
1
Views
38
Mar 7, 2023
Sidney Vianna
D
CFG application issues
danir30
Dec 15, 2022
Replies
0
Views
143
Dec 15, 2022
danir30
P
AIM 7351731 RFID reader immunity
phase90
Jan 29, 2020
Replies
5
Views
1,913
Dec 1, 2022
Highground
D
Initial Importer question
DeadPhoenix
Aug 18, 2022
Replies
1
Views
310
Nov 27, 2022
goldenguo
C
Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158
celticfrosting
Mar 2, 2018
Replies
3
Views
2,766
Sep 28, 2022
newtoquality
T
FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device
TomQA
Jun 16, 2022
2
Replies
13
Views
1,053
Aug 17, 2022
TomQA
N
UDI for OTS Components
newtoquality
Aug 11, 2022
Replies
1
Views
254
Aug 11, 2022
yodon
N
Can we take a part from 510k cleared medical device and use it in class I device?
Nissim Shaked
Aug 22, 2019
Replies
6
Views
1,022
Jul 22, 2022
Ronen E
C
Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices?
chloep17
Feb 10, 2012
Replies
2
Views
2,636
Jul 21, 2022
Parul Chansoria
I
21 CFR 806 Corrections and Removals
indubioush
May 24, 2022
Replies
2
Views
331
Jul 19, 2022
indubioush
C
FDA Medical Device Label Requirements - serial numbers
closdebois09
Mar 16, 2019
Replies
9
Views
5,844
May 27, 2022
sangeetha
C
How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)?
cjoiwei
Jan 10, 2022
Replies
4
Views
660
May 25, 2022
akp060
S
Testing an equipment for MRI Compatibility
shiftkoji
Feb 7, 2018
Replies
7
Views
2,813
Mar 23, 2022
Sam Lazzara
P
21 CFR 58 GLP Periodic Study Phase Inspection Report
PRFire
Mar 16, 2022
Replies
0
Views
278
Mar 16, 2022
PRFire
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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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