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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
  • Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
2 3 4 5
Replies
45
Views
22,403
cmeby
Discussions
P
UDI Registration - Class II Medical Device Software
2
Replies
11
Views
2,882
hchang
I
Multiple Indications in SaMD
Replies
8
Views
233
Watchcat
Marc
FDA safety scandal: 50K hidden reports of heart device malfunctioning - May 2019
Replies
3
Views
462
Highground
K
Unused Service Parts in Newly Manufactured Medical Device?
Replies
1
Views
67
Gisly
shimonv
Can you submit a traditional application for a class I device?
Replies
7
Views
191
Watchcat
W
Final Report re: Market withdrawal of radiation-emitting product
Replies
0
Views
59
wwdavid
M
California Board of Pharmacy License for Medical Devices??
Replies
6
Views
104
Maryvicki
M
Specimen storage medium for 866.2900 or 864.3250
Replies
4
Views
87
Morris Liu
P
AIM 7351731 RFID reader immunity
Replies
4
Views
902
Cecile
B
ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria
Replies
1
Views
882
Ref85
V
510 k submission RTA (Acceptance Checklist )
Replies
5
Views
195
Ajit Basrur
Watchcat
FDA vs NB Fees?
Replies
7
Views
256
Raisin picker
P
Is there a counterpart to the General Safety and Performance Regulations for the USA?
Replies
4
Views
749
Watchcat
Watchcat
510(k)s and "Innovation"?
Replies
2
Views
149
Watchcat
L
Documentation of Medical Device Software Verification activities
Replies
7
Views
2,033
Hirvo
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