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
20,634
cmeby
Discussions
Aliken
Fluoride sustained-release device
Replies
0
Views
51
Aliken
C
21 CFR 803 malfunction detected during packaging - report?
Replies
1
Views
88
SKM.Sunil
J
Is Device Tracking Card an actual requirement under FDA regulation?
Replies
0
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106
Jen
R
Can I have 1 Medical Device with 3 different names?
2
Replies
13
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5,141
Sicco
T
510(k) submission - Which name should I use in the submission?
Replies
3
Views
193
monoj mon
shimonv
FDA News FDA guidance on Multiple Function Device Products (8/2020)
Replies
1
Views
214
yodon
Watchcat
Advantages to pursuing a Special 510(k) instead of a Traditional 510(k)
Replies
5
Views
279
monoj mon
N
FDA UDI - Label vs. Labeling - Does the insert need to include UDI?
Replies
0
Views
257
nz1nz2
A
21 CFR part 11 - section 11.100 - Electronic Signature Certification
Replies
6
Views
353
Ajit Basrur
K
510K new manufacturer but same components
Replies
6
Views
203
katiesam
K
510(k) expanding the indication for use for a cleared device
Replies
9
Views
802
katiesam
K
FDA Premarket Cybersecurity Guidance - 4 questions
Replies
5
Views
519
colinkmorgan
M
Should 510(k) Predicates be Actively Listed Devices?
2
Replies
12
Views
422
Watchcat
L
Medical-grade power adapter labeling
Replies
2
Views
202
lin2020
Watchcat
FDA will not tolerate fraud…meaning what, exactly?
Replies
6
Views
425
Watchcat
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