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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
18,498
cmeby
Discussions
M
DI format for UDI after we have registered it with GS1
Replies
0
Views
47
monoj mon
Watchcat
Inside the Bubble 2019
Replies
2
Views
84
Watchcat
H
New 510K VS Documents about design change.
Replies
1
Views
34
primavesvera
P
21 CFR 807.81 When a premarket notification submission is required
Replies
0
Views
27
PacoRabanez
P
Medical Device not on commercial distribution but installed in the establishment. 510k?
2
Replies
10
Views
139
PacoRabanez
T
Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial
Replies
9
Views
100
Watchcat
D
Pre-Submission after 510(K) Submission?
Replies
4
Views
130
primavesvera
M
How to deal with FDA after not reporting anything for several years
2
Replies
14
Views
341
Ronen E
K
Reporting a Change of Contract Manufacturer for a 510(k) cleared device
Replies
2
Views
55
KMac
D
Experience with De Novo applications
Replies
8
Views
151
Watchcat
S
Referring to previously submitted biocompatibility results in a new 510(k) submission
Replies
1
Views
122
Asia78
M
CBE (Change Being Effected) 510(k) Submission
Replies
2
Views
76
Ronen E
P
Is there a counterpart to the General Safety and Performance Regulations for the USA?
Replies
2
Views
78
Watchcat
R
FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed
Replies
5
Views
295
Al Rosen
J
FDA Class 1 Medical Device UDI requirements
Replies
6
Views
401
AUDITGIRL
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