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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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Labeling for Medical Device Samples - Surgical instruments
Monday at 2:53 PM
Ed Panek
Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
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730
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3.8K
Threads
730
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E
Medical Device Manufacturer vs. Specification Developer
Sunday at 3:11 PM
EmiliaBedelia
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FDA and ISO 13485 News
Ed Panek
Dec 8, 2023
Replies
9
Views
668
Yesterday at 3:09 PM
SSchoepel
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FDA recognition of ISO14155.
JenniferMM
Mar 31, 2024
Replies
2
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173
Apr 1, 2024
JenniferMM
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Class II/III and Component Manufacturer Moving to New Location
SpiderMonkey
Mar 28, 2024
Replies
2
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126
Mar 31, 2024
Aj grant
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Off Label Use
margadia
Mar 29, 2024
Replies
3
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148
Mar 29, 2024
yodon
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Manifacturing data requirements for 510(k)
Vika.urbano
Mar 27, 2024
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1
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123
Mar 29, 2024
yodon
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Adding accessory to an existing Class ll registered device
RachelM
Aug 30, 2023
Replies
7
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377
Mar 22, 2024
Haresh
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Class I Exempt FDA Question
jbm12
Feb 13, 2024
Replies
2
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273
Mar 15, 2024
jbm12
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Selling same device as IVD and RUO
REG12
Feb 20, 2023
2
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10
Views
800
Mar 11, 2024
akp060
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UDI Management
Ed Panek
Mar 5, 2024
Replies
1
Views
181
Mar 5, 2024
LUFAN
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Why a 510k can includes multiple medical devices with difference indication for use
Emma2010
Dec 14, 2023
Replies
7
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715
Mar 4, 2024
Emma2010
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Complaint Handling Under QMSR
LUFAN
Jan 31, 2024
2
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12
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676
Mar 4, 2024
Chrisx
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QMSR changes to inspection of records
Chrisx
Feb 28, 2024
Replies
1
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193
Feb 28, 2024
LUFAN
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Letter to File
LTran
Feb 16, 2024
Replies
0
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179
Feb 16, 2024
LTran
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Private Labeling a Class II device to be used with our device
B-Kabitz
Feb 7, 2024
Replies
2
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190
Feb 13, 2024
B-Kabitz
B
Foreign Language Label
Ed Panek
Jan 25, 2024
Replies
1
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228
Jan 25, 2024
DallasThomasIQVIA
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Medical Device Related Regulations
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