Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
Q
Did you use consultants for UDI?
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4
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2K
QA-Man
Q
shimonv
Changing the Label of a Medical Device product in the field
Replies
5
Views
3K
shimonv
shimonv
Ronen E
FDA releases new draft guidance on when to submit a 510(k) for device modification
2
Replies
10
Views
4K
Ronen E
Ronen E
Q
Special 510(k) or New Traditional - Currently Inactive Products
Replies
2
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2K
mihzago
mihzago
Ronen E
FDA issues draft guidance on form & content of UDI
Replies
0
Views
2K
Ronen E
Ronen E
I
Buying a competitors product for SE testing
Replies
3
Views
2K
Chrisx
C
K
HIPAA - Subcontractors and suppliers
Replies
2
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2K
Marc
Marc
E
Special 510(k) for software change
Replies
1
Views
2K
Ronen E
Ronen E
R
Medical Device and Accessory Establishment Registration and Listing Query
Replies
7
Views
3K
baseball2k2k
B
I
Request an FDA GUDID Account - Problems
Replies
3
Views
2K
initdeep
I
N
UDI implementation with contract manufacturer
Replies
2
Views
2K
NicoleinFlorida
N
W
New 510k required for a material change?
Replies
9
Views
3K
Ronen E
Ronen E
I
Catch up 510(k) - Non-significant changes were made
Replies
1
Views
4K
Mark Meer
M
N
How to interpret the definition of clinical and preclinical trials?
Replies
3
Views
2K
normhowe
N
I
GUDID listing - Inputting data into the GUDID database
Replies
3
Views
2K
image182
I
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