Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
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Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices?
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2
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3K
Parul Chansoria
Parul Chansoria
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FDA Medical Device Label Requirements - serial numbers
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9
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7K
sangeetha
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How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)?
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4
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919
akp060
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Testing an equipment for MRI Compatibility
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7
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3K
Sam Lazzara
Sam Lazzara
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21 CFR 58 GLP Periodic Study Phase Inspection Report
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0
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468
PRFire
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Has the facility been inspected? question in Certificate to Foreign Government application
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0
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573
jerryz
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Watchcat
UDI Timeframes?
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7
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952
monoj mon
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Private Label Distribution - US
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2
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1K
DannyK
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FDA Class 1 Medical Device UDI requirements
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20
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7K
AngelaLaw
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Watchcat
REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen?
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0
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718
Watchcat
Watchcat
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Final rule on use of symbols on labeling - Symbols without text under some conditions
2
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13
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6K
Cyprusbirthdaycake
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How to find a good 510(k) submission training?
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2
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673
Watchcat
Watchcat
Watchcat
REGULATORY WATCHCAT De Novo Post-Mortem 5 – What's the Rush?
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0
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501
Watchcat
Watchcat
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Worst case HLD sample for efficacy studies
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0
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559
Parsely
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FDA UDI Question - Class II Medical Device
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2
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1K
Watchcat
Watchcat
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