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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
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FDA - Change of Manufacturings Site to Contract Manufacturer in China
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4
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NoaWeber
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T
FDA Design and Development Planning Requirements
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3
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Turquoise202
T
B
DMR (Device Master Record) For Contract Manufacturers
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8
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9K
pbojsen
pbojsen
Y
Shelf Life of Non-Sterile Disposable Drug Inhaler
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1
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NikkiQSM
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What testing would you run to determine if a device is "Clean"?
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4
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normzone
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S
Traceability and the initiation of GMP Activities
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6
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Ronen E
Ronen E
A
Where to download free Medical Device Symbols
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10
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Pads38
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somashekar
Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer
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11
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Ajit Basrur
Ajit Basrur
shimonv
Over-Labeling Sterile Packaging - Shelf Life
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3
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shimonv
shimonv
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Are internally found Medical Device Software "Bugs" Complaints?
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3
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uhohraggy
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M
Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design?
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4
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William55401
William55401
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Should Biocompatibility Tests be performed on Production Samples?
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9
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Access2hc
A
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  • Poll
Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market?
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5
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shimonv
shimonv
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Is it legal to attend a trade show while you have a 510(k) application pending?
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2
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rwend07
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FDA Email Address needed for CECATS
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1
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medic61
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