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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
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
2 3 4 5
Replies
45
Views
19,309
cmeby
Discussions
K
EUA for COVID-19 Prognostics
Replies
1
Views
86
indubioush
M
Regulatory clearance pathways for surgical masks/N95 respirators
Replies
2
Views
102
KatieQA
J
FDA Class 1 Medical Device UDI requirements
2
Replies
19
Views
1,093
DitchDigger
Watchcat
Are De novos failing?
Replies
4
Views
142
Watchcat
M
Demonstrating battery safety in 510(K) submission for the FDA
Replies
9
Views
2,146
MikeKilkelly
Watchcat
Year of the Regulatory Watchcat
Replies
6
Views
148
Watchcat
P
AIM 7351731 RFID reader immunity
Replies
1
Views
101
bender991
M
Advertising medical devices in the U.S
Replies
2
Views
96
shimonv
A
MAH license transfer (medical device registrant) procedure in Indonesia
Replies
0
Views
87
Ally Bahsram
Watchcat
DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018
Replies
2
Views
139
Watchcat
Watchcat
Inside the Bubble 2019
Replies
8
Views
362
Watchcat
M
Timing of 510k submission
Replies
9
Views
245
kdawg
K
Completing Design Controls after 510(k) Clearance
2
Replies
11
Views
351
Watchcat
G
Do HIPAA Rules Apply to a 3rd Party Logistics Shipper?
Replies
2
Views
119
Watchcat
Ed Panek
Adverse Event Clinical Trial using a 510K approved Device
Replies
6
Views
196
Watchcat
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