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
18,297
cmeby
Discussions
J
FDA Class 1 Medical Device UDI requirements
Replies
5
Views
263
Ajit Basrur
F
Replacement Bone Screws - Traditional 510(k) or Special 510(k)?
Replies
6
Views
84
Ronen E
C
21 CFR Part 11- What about handwritten signatures?
Replies
1
Views
91
chris1price
J
Latex Adhesive Labels used in Medical Device Packaging
Replies
7
Views
2,008
chris1price
Watchcat
Office of In Vitro Diagnostic and Radiological Health (OIR) De novos 2018
Replies
1
Views
59
Marc
Watchcat
Informational ODE DE NOVOs 2018
Replies
1
Views
51
Watchcat
Watchcat
Informational Proposed Rule - De novos - 2019
Replies
1
Views
55
Marc
Watchcat
Informational FDA Proposal to "Modernize" the 510(k) - 2019
Replies
1
Views
82
Marc
B
510(k) clearance claim on medical device product packaging
Replies
6
Views
126
craiglab
S
Referring to previously submitted biocompatibility results in a new 510(k) submission
Replies
0
Views
66
shimonv
R
Addressing training requirements - 21 CFR Part 820.25 (1) & (2)
Replies
4
Views
195
John Predmore
A
How long does it take US FDA to issue a Warning Letter Close Out Letter
Replies
2
Views
2,804
Chuck
B
ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria
Replies
0
Views
78
Bharti Dhaundiyal
Marc
FDA safety scandal: 50K hidden reports of heart device malfunctioning - May 2019
Replies
2
Views
176
Watchcat
P
FDA inspections and electronic signatures
Replies
2
Views
111
pkost
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