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
23,152
cmeby
Discussions
G
FDA clearance for a device that can't be used clinically (at present)
Replies
5
Views
165
Watchcat
Watchcat
UDI Timeframes?
Replies
5
Views
98
monoj mon
K
UDI Labeling for Clinical Investigational Device
Replies
4
Views
3,129
anazuzo
shimonv
Where do you place Human Factors report in a 510(k) application?
Replies
3
Views
127
Watchcat
Watchcat
REGULATORY WATCHCAT De novo Post Mortem 2 - Disclosure and Accountability
2
Replies
11
Views
291
Watchcat
Watchcat
Does Regulatory Affairs put the "no" in innovation?
2
Replies
14
Views
375
Watchcat
Watchcat
REGULATORY WATCHCAT De Novo Post-Mortem 3 - Rearranging the Regs
Replies
0
Views
44
Watchcat
Watchcat
New Draft Guidance on Content of Premarket Submissions for Software Device "Functions"
Replies
2
Views
77
Watchcat
Watchcat
Software validation vs design V&V?
2 3
Replies
27
Views
718
Tidge
Watchcat
How are pre-subs going these days?
Replies
2
Views
134
Watchcat
Watchcat
REGULATORY WATCHCAT De novo Post Mortem 1 - Regulatory Religion
Replies
0
Views
88
Watchcat
Watchcat
REGULATORY WATCHCAT De novo Post Mortem
Replies
0
Views
88
Watchcat
Watchcat
REGULATORY WATCHCAT - RIP "Mini-PMA"
Replies
0
Views
73
Watchcat
Watchcat
CDRH Proposed New Guidance Documents, FY2022
Replies
2
Views
94
Tidge
DanBOS
Registration and Listing Timing
Replies
2
Views
187
monoj mon
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