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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
18,762
cmeby
Discussions
Ed Panek
Adverse Event Clinical Trial using a 510K approved Device
Replies
6
Views
83
Watchcat
K
Reporting a Change of Contract Manufacturer for a 510(k) cleared device
Replies
5
Views
129
Watchcat
O
Hospital-Developed, In-House Device - FDA Clearance?
2
Replies
19
Views
216
Watchcat
S
Is UDI required for Spare Parts?
Replies
4
Views
1,933
Asia78
D
FDA Approved Class II Medical Device?
2
Replies
11
Views
165
Ronen E
M
Timing of 510k submission
Replies
8
Views
99
Ronen E
A
Convenience Kit Requirements
2
Replies
10
Views
319
Watchcat
M
Manufacturer address on the label
2
Replies
12
Views
185
monoj mon
M
510(k) 10993 Biocompability Testing
2
Replies
15
Views
224
Watchcat
M
Standards Subscription Service and Standards Tracking Service Pros and Cons?
Replies
3
Views
100
craiglab
R
UDI for US - Third Party device Repackager
Replies
9
Views
135
Ramdan
R
Can anyone please explain this? (510k submission requirement)
2
Replies
14
Views
276
Marcelo
R
ISO 10079-1:2014 on electric powered nasal aspirator
Replies
0
Views
74
Rachute
Watchcat
Inside the Bubble 2019
Replies
3
Views
144
Watchcat
Watchcat
De novo Summary (ODE 2015-2018)
Replies
2
Views
70
Watchcat
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