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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
Sidney Vianna
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FDA plans to use ISO 13485 for Medical Devices Regulation
2
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13
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3,175
bkelly79
E
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Finding Medical Device Listing Numbers on the USA's FDA site
2
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19
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42,773
Ronen E
K
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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5,696
Julie O
Marc
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ISO 13485, ISO 14971 and other Medical Device Related Forums
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0
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8,529
Marc
Ajit Basrur
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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13,337
Ajit Basrur
Discussions
K
Private Labeler is Relabeler
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2
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53
Ed Panek
placebo_master
Verification Protocols - when to implement them (and when to skip in lieu of a report)
Replies
4
Views
143
Tidge
Watchcat
Change Request Documents - What's Typical These Days?
2
Replies
14
Views
348
Watchcat
Ed Panek
FDA Remote Regulatory Assessment (RRA) Overview
Replies
9
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238
Ed Panek
Ed Panek
Apple Provides New Medical Device Cautions
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2
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208
Jaydub
Watchcat
De novo Final Rule Pending - Inspections
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0
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63
Watchcat
J
Promoting and marketing of a non approved device
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6
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324
MnMedDev
C
UDI Label Verification - How do we ensure the barcode is correct and prove it?
2
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18
Views
5,050
LUFAN
M
ASTM F1717 Static and Dynamic Testing
Replies
2
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137
QM_123
E
Component manufacturer or contract manufacturer ?
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7
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307
LUFAN
L
EOL milestone in Medical Devices Regulations
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2
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115
LiB0909
V
PPQ Shipping into US
Replies
7
Views
204
indubioush
Ed Panek
2020 FDA Top Ten Observations
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3
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247
Tidge
DanBOS
Cloud Connected Medical Device
Replies
1
Views
138
mihzago
R
Does FDA allow e-labeling?
Replies
4
Views
5,393
Mark Meer
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