Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

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
17,508
cmeby
Discussions
C
Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring)
Replies
3
Views
871
melancholy
S
Creating a new commercial product based on a modification to an existing product
Replies
4
Views
171
shimonv
B
Manufacturing Company Address Change - implications for FDA
Replies
1
Views
75
drhkp
S
Where did FDA 510(K) form 3654 go?
Replies
1
Views
94
Ronen E
S
MAUDE database and similar devices
Replies
5
Views
253
Ronen E
K
CFG (certificate of foreign government) Requestor
Replies
0
Views
42
kellascat
B
Can you guys help me figure out formatting a 510K
2
Replies
11
Views
1,538
Marc
C
FDA Medical Device Label Requirements - serial numbers
Replies
2
Views
145
Al Rosen
T
Control of Promotional/Advertising Materials
2
Replies
11
Views
906
sarushka
K
510(k) expanding the indication for use for a cleared device
Replies
6
Views
171
katiesam
M
Demonstrating battery safety in 510(K) submission for the FDA
Replies
8
Views
1,731
Al Rosen
S
Medical Device Manufacturer vs. Specification Developer
Replies
1
Views
1,058
EBD
A
How to write a US FDA proof MDR procedure?
Replies
5
Views
3,428
Jean_B
S
21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing
Replies
1
Views
167
chris1price
K
Letter to file vs Special 510 for additional accessory in orthopaedic kit
Replies
1
Views
195
Chrisx
You must log in or register to post here.
Top Bottom