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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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US Medical Device Regulations
United States Medical Device Regulations
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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1.5K
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H
Change to an FDA Cleared Device
Saturday at 6:54 AM
Haresh
Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
Threads
729
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3.8K
Threads
729
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Is it acceptable it is to list new products under an existing 510(k)?
Monday at 2:28 PM
LUFAN
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V
Manifacturing data requirements for 510(k)
Vika.urbano
Yesterday at 3:47 PM
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0
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42
Yesterday at 3:47 PM
Vika.urbano
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Adding accessory to an existing Class ll registered device
RachelM
Aug 30, 2023
Replies
7
Views
336
Friday at 6:48 AM
Haresh
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Class I Exempt FDA Question
jbm12
Feb 13, 2024
Replies
2
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217
Mar 15, 2024
jbm12
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R
Selling same device as IVD and RUO
REG12
Feb 20, 2023
2
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10
Views
740
Mar 11, 2024
akp060
A
UDI Management
Ed Panek
Mar 5, 2024
Replies
1
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129
Mar 5, 2024
LUFAN
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E
Why a 510k can includes multiple medical devices with difference indication for use
Emma2010
Dec 14, 2023
Replies
7
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656
Mar 4, 2024
Emma2010
E
L
Complaint Handling Under QMSR
LUFAN
Jan 31, 2024
2
Replies
12
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560
Mar 4, 2024
Chrisx
C
C
QMSR changes to inspection of records
Chrisx
Feb 28, 2024
Replies
1
Views
158
Feb 28, 2024
LUFAN
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L
Letter to File
LTran
Feb 16, 2024
Replies
0
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154
Feb 16, 2024
LTran
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B
Private Labeling a Class II device to be used with our device
B-Kabitz
Feb 7, 2024
Replies
2
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154
Feb 13, 2024
B-Kabitz
B
FDA and ISO 13485 News
Ed Panek
Dec 8, 2023
Replies
7
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583
Feb 1, 2024
LUFAN
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Foreign Language Label
Ed Panek
Jan 25, 2024
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1
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196
Jan 25, 2024
DallasThomasIQVIA
Using an old predicate
shimonv
Jan 16, 2024
Replies
8
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359
Jan 24, 2024
EmiliaBedelia
E
Package Inserts for Single Packed Implantable
austin_howell
Jan 16, 2024
Replies
3
Views
182
Jan 24, 2024
indubioush
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FDA 510(k)
nthangcnhh
Jan 18, 2024
Replies
1
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190
Jan 24, 2024
indubioush
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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