21 CFR Part 820 - US FDA Quality System Regulations (QSR)

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
Sidney Vianna
  • Sticky
FDA plans to use ISO 13485 for Medical Devices Regulation
2
Replies
12
Views
2,059
Ajit Basrur
E
Finding Medical Device Listing Numbers on the USA's FDA site
2
Replies
19
Views
37,178
Ronen E
K
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
Replies
6
Views
5,340
Julie O
Marc
  • Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
Replies
0
Views
8,173
Marc
Ajit Basrur
  • Locked
  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
Replies
0
Views
12,791
Ajit Basrur
Discussions
A
FDA Class Classification for a cabinet
Replies
1
Views
72
William55401
A
What is the difference between Design Process, Process Design and Design Control?
Replies
2
Views
106
A.Khan
A
Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable)
Replies
4
Views
155
Aphel
H
Who should be listed as the manufacturer/distributor on the box?
2
Replies
15
Views
369
Emma2010
gunnyshore
Form FDA 3500A MedWatch eSubmitter
Replies
5
Views
184
lizVR
V
Writing a Pre-Submission to the FDA
2 3 4 5
Replies
42
Views
8,655
akp060
S
A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements
Replies
4
Views
141
SANE
F
UDI Registration - Who is responsible for Registration of the Device?
2
Replies
11
Views
338
monoj mon
dinaroxentool
Question about FDA Classification of a Device
Replies
3
Views
250
duinyk
Stoic
Manual soldering processes - 100% verifiable, or always requiring validation?
2
Replies
13
Views
360
Bev D
J
Sub-supplier change from manual to automated process - same specs - Report to FDA?
Replies
2
Views
178
Ed Panek
shimonv
Storage of finished medical devices per 21 CFR Part 820.150
Replies
9
Views
2,333
Ed Panek
C
Documentation for items used for Design Verification
Replies
4
Views
180
indubioush
P
Design verification driven by new equipment. How is this different than process validation?
Replies
1
Views
164
yodon
K
510(K) File eCopy Submission
2
Replies
16
Views
638
primavesvera
You must log in or register to post here.
Top Bottom