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
19,997
cmeby
Discussions
K
FDA Premarket Cybersecurity Guidance - 4 questions
Replies
2
Views
181
Kyunghwan Kim
M
Should 510(k) Predicates be Actively Listed Devices?
Replies
7
Views
92
Watchcat
L
Medical-grade power adapter labeling
Replies
2
Views
76
lin2020
Watchcat
FDA will not tolerate fraud…meaning what, exactly?
Replies
6
Views
168
Watchcat
L
FDA Biocompatibility Requirements - Transitory Contact
Replies
1
Views
99
planB
S
Immobilization and patient positioning for radiotherapy
2
Replies
10
Views
190
monoj mon
D
Importing a general wellness low risk product
Replies
3
Views
50
shimonv
A
21 CFR part 11 - section 11.100 - Electronic Signature Certification
Replies
3
Views
97
Ajit Basrur
M
How to Select FDA Medical Device Product Code?
2
Replies
10
Views
571
Watchcat
N
Can we take a part from 510k cleared medical device and use it in class I device?
Replies
3
Views
247
duinyk
S
Selling Clinical Practice Advice
Replies
7
Views
219
markl368
Watchcat
FDA Webinar Series - N95 Respirators
Replies
0
Views
92
Watchcat
L
N95 Respirators - Can we label our masks as N95?
Replies
8
Views
249
monoj mon
A
Medical device Reporting : Good Faith Effort for Additional information
Replies
2
Views
173
Watchcat
N
IVD Lot Numbers and Expiration Dates - 21 CFR 809.10
Replies
3
Views
1,357
tebusse
You must log in or register to post here.
Top Bottom