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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
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Finding Medical Device Listing Numbers on the USA's FDA site
2
Replies
19
Views
28,137
Ronen E
Sidney Vianna
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FDA plans to use ISO 13485 for Medical Devices Regulation
Replies
8
Views
992
Marcelo Antunes
K
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
Replies
6
Views
4,901
Julie O
Marc
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ISO 13485, ISO 14971 and other Medical Device Related Forums
Replies
0
Views
7,746
Marc
Ajit Basrur
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Replies
0
Views
11,892
Ajit Basrur
Discussions
K
Distribution medical devices to US Embassies
Replies
1
Views
54
Sidney Vianna
Ed Panek
Splitting UI (User Interface) into two development paths
Replies
4
Views
49
Ed Panek
S
Bringing a Medical Device Sample from a Foreign Country into the US
Replies
6
Views
2,541
Kathy Moon
Q
Device History Records Maintenance - Discontinued the use of the Product
Replies
5
Views
1,585
burkyle
Ajit Basrur
Requirements for Refurbishment of Medical Devices in Mexico
2
Replies
10
Views
146
Genaro Luevano
E
Declarations of conformity and summary reports
Replies
7
Views
4,812
Pads38
J
FDA Routine Inspection Pre-Anouncement - What will be checked?
Replies
7
Views
2,090
chris1price
Ajit Basrur
How do I label this commercial product ready for clinical study?
Replies
3
Views
85
Ronen E
P
510(k) cleared, Rx only and home use
Replies
9
Views
290
PearlKetchup
A
Does any one have FDA 21 CFR Part 820 QSR training material?
Replies
5
Views
3,069
Ronen E
W
FDA Labeling Requirements - Instruction for Use Content
Replies
5
Views
2,368
Ronen E
H
When is Calibration not required?
2
Replies
11
Views
7,614
med_cert
M
Has anyone here assessed the latest Abbreviated 510(K) guidance document?
Replies
1
Views
108
MDRexpert
Ed Panek
User Feedback both negative and positive and acting upon those metrics
Replies
4
Views
135
somashekar
Q
FDA:Expansion of the Abbreviated 510(k) 2 Program
Replies
1
Views
519
Jnks_Meddev
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