Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
FAQs
Sam Lazzara
  • Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
2 3 4 5
Replies
45
Views
21,088
cmeby
Discussions
C
Warehousing two separate components to a finished device while meeting regulations
Replies
7
Views
125
indubioush
L
Medical Device Registration in Macau
Replies
1
Views
155
Watchcat
L
Question about biocompatiblity of medical device - Contacts with patient skin
2
Replies
15
Views
4,633
planB
Watchcat
Free EUA (Emergency Use Authorization)!
Replies
4
Views
140
Watchcat
H
510k with Contract Manufacturer
Replies
2
Views
161
HH0312
U
Certificate of Free Sale
Replies
7
Views
250
Udirn1
Aliken
Fluoride sustained-release device
Replies
4
Views
219
Aliken
K
Two FDA questions regarding UDI (and potentially 803.52 MDR)
Replies
0
Views
225
Kat C
N
FDA UDI - Label vs. Labeling - Does the insert need to include UDI?
Replies
1
Views
466
Kat C
C
21 CFR 803 malfunction detected during packaging - report?
Replies
1
Views
140
SKM.Sunil
J
Is Device Tracking Card an actual requirement under FDA regulation?
Replies
0
Views
213
Jen
R
Can I have 1 Medical Device with 3 different names?
2
Replies
13
Views
5,394
Sicco
T
510(k) submission - Which name should I use in the submission?
Replies
3
Views
267
monoj mon
shimonv
FDA News FDA guidance on Multiple Function Device Products (8/2020)
Replies
1
Views
327
yodon
Watchcat
Advantages to pursuing a Special 510(k) instead of a Traditional 510(k)
Replies
5
Views
382
monoj mon
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