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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
J
US Manufacturer of Export Only Exempt Products applying for CFG
Replies
1
Views
1K
Emma2010
E
I
Bioburden and Endotoxin (LAL) Testing proposal help
Replies
6
Views
8K
planB
planB
H
How to register my establishment and appropriate labeling
Replies
3
Views
341
EmiliaBedelia
E
E
Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)?
2
Replies
10
Views
4K
CDCCarmela
C
A
Pre-Sub Meeting
Replies
6
Views
396
Ed Panek
Ed Panek
A
Registration requirements for custom branded device
2
Replies
10
Views
2K
XRAY_3121
XRAY_3121
I
Product Lifetime on Labeling
Replies
1
Views
283
EmiliaBedelia
E
Ed Panek
Statistics Question
Replies
4
Views
414
Steve D
S
Q
510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval
2
Replies
13
Views
8K
JT Tung
J
C
Required Designated Roles - 21 CFR 820
Replies
3
Views
375
Ed Panek
Ed Panek
B
Medwatch - Manufacture Reference # AKA Complaint #
Replies
1
Views
274
Tidge
T
J
Establishment registration FDA 'Foreign exporter'
Replies
5
Views
6K
MJW66
M
A
21CFR807.25 (d) Owner-Operator Contact question
Replies
2
Views
2K
Highground
Highground
B
Gamma Irradiation - Multiple doses to achieve the Dose range
Replies
1
Views
300
planB
planB
D
Rx only symbol on Drapes
Replies
2
Views
212
LUFAN
L
You must log in or register to post here.
Top Bottom