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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
18,957
cmeby
Discussions
J
FDA Class 1 Medical Device UDI requirements
2
Replies
10
Views
606
DitchDigger
A
MAH license transfer (medical device registrant) procedure in Indonesia
Replies
0
Views
40
Ally Bahsram
Watchcat
DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018
Replies
2
Views
76
Watchcat
Watchcat
Inside the Bubble 2019
Replies
8
Views
306
Watchcat
M
Timing of 510k submission
Replies
9
Views
164
kdawg
K
Completing Design Controls after 510(k) Clearance
2
Replies
11
Views
191
Watchcat
G
Do HIPAA Rules Apply to a 3rd Party Logistics Shipper?
Replies
2
Views
86
Watchcat
Ed Panek
Adverse Event Clinical Trial using a 510K approved Device
Replies
6
Views
138
Watchcat
K
Reporting a Change of Contract Manufacturer for a 510(k) cleared device
Replies
5
Views
177
Watchcat
O
Hospital-Developed, In-House Device - FDA Clearance?
2
Replies
19
Views
307
Watchcat
S
Is UDI required for Spare Parts?
Replies
4
Views
1,984
Asia78
D
FDA Approved Class II Medical Device?
2
Replies
11
Views
238
Ronen E
A
Convenience Kit Requirements
2
Replies
10
Views
350
Watchcat
M
Manufacturer address on the label
2
Replies
12
Views
214
monoj mon
M
510(k) 10993 Biocompability Testing
2
Replies
15
Views
285
Watchcat
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