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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
E
Finding Medical Device Listing Numbers on the USA's FDA site
2
Replies
19
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32,136
Ronen E
Sidney Vianna
  • Sticky
FDA plans to use ISO 13485 for Medical Devices Regulation
Replies
8
Views
1,523
Marcelo
K
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
Replies
6
Views
5,170
Julie O
Marc
  • Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
Replies
0
Views
8,030
Marc
Ajit Basrur
  • Locked
  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
Replies
0
Views
12,265
Ajit Basrur
Discussions
R
When does the FDA consider a component a medical device?
2
Replies
17
Views
262
Ronen E
Watchcat
Does 820.30 include the manufacturing process?
Replies
2
Views
84
Ronen E
N
Risk Management besides mandated FDA requirements
Replies
1
Views
140
yodon
D
RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements
Replies
5
Views
4,096
Jaydub
M
Labeling for off-label use - Prevention of off-label use of a medical device
Replies
1
Views
142
Ronen E
V
Writing a Pre-Submission to the FDA
2 3
Replies
24
Views
6,013
Veneto
M
Search for predicates to see what claims are being made for those predicates
Replies
1
Views
118
lkamer
C
FDA Registration Requirements for Multiple Sites
Replies
8
Views
234
Ajit Basrur
F
FDA-registration and inspection cost
Replies
1
Views
113
shimonv
M
Questions regarding Medical Device Software "Level of Concern"
Replies
3
Views
1,709
Pads38
D
Preventive Maintenance Implementation
Replies
5
Views
299
John Broomfield
J
FDA Establishment Registration Foreign Manufacturer RUO only
Replies
1
Views
106
indubioush
T
Potential Off-Label Use question
Replies
5
Views
228
tebusse
K
820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3
Replies
0
Views
177
Kjenks1
T
US FDA Medical Device Reporting SOP help
Replies
3
Views
4,341
vidhya
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