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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
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3
4
5
Replies
45
Views
27K
Jun 16, 2015
cmeby
C
Discussions
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Is it acceptable it is to list new products under an existing 510(k)?
image182
Dec 17, 2014
2
Replies
16
Views
4K
Monday at 2:28 PM
LUFAN
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E
Re-importing exported medical devices into the US
ERM-Reg
Jan 31, 2024
Replies
0
Views
91
Jan 31, 2024
ERM-Reg
E
D
Importing a general wellness low risk product
duinyk
Jun 25, 2020
Replies
4
Views
978
Jan 31, 2024
Haresh
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Limulus Amebocyte Lysate (LAL) Testing: A necessity on every lot?
mimic
Aug 6, 2009
2
Replies
17
Views
7K
Jan 18, 2024
planB
E
FDA final guidance on Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J
Emma2010
Dec 14, 2023
Replies
0
Views
139
Dec 14, 2023
Emma2010
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Operators Manual update to product in the field
I_Moy
Nov 1, 2023
Replies
2
Views
192
Nov 3, 2023
yodon
Y
Is UDI required on the Packaging of a Serviced/Repaired Medical Device?
shimonv
Sep 12, 2018
Replies
5
Views
2K
Oct 20, 2023
Edgar Trejo
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New GTIN (DI) required?
Oleander
Oct 9, 2021
Replies
1
Views
662
Oct 9, 2023
YellowQCPro
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CFG from USFDA to Egypt - Import entry number
GPSteve
Oct 4, 2023
Replies
2
Views
249
Oct 4, 2023
GPSteve
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510(K) Cyber Security Documentation for Pre-market Submission (Templates)
vivekcek
Sep 24, 2014
Replies
9
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5K
Sep 27, 2023
yodon
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Taiwan Medical Device Training?
RRamsay
Sep 4, 2023
Replies
0
Views
134
Sep 4, 2023
RRamsay
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UDI for device programmer and software
tehuff
Aug 14, 2023
Replies
2
Views
259
Aug 14, 2023
tehuff
T
Human Factors for a DE Novo AI device for FDA review SaMD
Ed Panek
Jun 27, 2023
Replies
0
Views
168
Jun 27, 2023
Ed Panek
S
Differentiate between Critical and High risk vendors
SGquality
Jun 21, 2023
Replies
3
Views
227
Jun 21, 2023
yodon
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Addressing training requirements - 21 CFR Part 820.25 (1) & (2)
RCW
May 24, 2019
Replies
6
Views
3K
Jun 14, 2023
RCW
R
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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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