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
25,260
cmeby
Discussions
M
CBE (Change Being Effected) 510(k) Submission
Replies
8
Views
3,513
EmiliaBedelia
J
ASTM F965 Laryngoscopes
Replies
1
Views
38
Sidney Vianna
D
CFG application issues
Replies
0
Views
143
danir30
P
AIM 7351731 RFID reader immunity
Replies
5
Views
1,913
Highground
D
Initial Importer question
Replies
1
Views
310
goldenguo
C
Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158
Replies
3
Views
2,766
newtoquality
T
FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device
2
Replies
13
Views
1,053
TomQA
N
UDI for OTS Components
Replies
1
Views
254
yodon
N
Can we take a part from 510k cleared medical device and use it in class I device?
Replies
6
Views
1,022
Ronen E
C
Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices?
Replies
2
Views
2,636
Parul Chansoria
I
21 CFR 806 Corrections and Removals
Replies
2
Views
331
indubioush
C
FDA Medical Device Label Requirements - serial numbers
Replies
9
Views
5,844
sangeetha
C
How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)?
Replies
4
Views
660
akp060
S
Testing an equipment for MRI Compatibility
Replies
7
Views
2,813
Sam Lazzara
P
21 CFR 58 GLP Periodic Study Phase Inspection Report
Replies
0
Views
278
PRFire
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