Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
D
Documentation Requirements for Firmware in a 510(k) Submission
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1
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3K
yodon
Y
D
Down Classifying a Medical Device from Class II to Class I
2 3
Replies
21
Views
5K
Marcelo
M
M
FDA's expectation for validating OTS software updates
Replies
8
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8K
MC Eistee
M
Q
FDA To Publish Powdered Glove Ban Monday (December 19, 2016)
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0
Views
1K
QA-Man
Q
Q
Medical Device Establishment Registration/Listing for Foreign Private Labeler
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8
Views
3K
Ronen E
Ronen E
M
UDI - Rechargeable Batteries and Charger
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5
Views
3K
Ronen E
Ronen E
D
Use of clinical data in a 510(k) submission
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6
Views
3K
Julie O
J
K
Medical Device Listing for 801(e) Export of Uncleared 510(k)able Device
Replies
5
Views
2K
shimonv
shimonv
N
FDA Requirements for Animal Laboratory Testing (Harmonic Scalpel)
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1
Views
2K
bjohnsonrli
B
shimonv
FDA guidance on Postmarket Surveillance
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1
Views
2K
Julie O
J
Q
Open Medical Device Recall: Are there consequences?
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1
Views
2K
shimonv
shimonv
Pmarszal
Clarification for 21 CFR Part 11.100 - General Requirements
2
Replies
14
Views
7K
Pmarszal
Pmarszal
Pmarszal
FDA Global UDI Database: Record Submission Retention
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1
Views
2K
QA-Man
Q
J
US Listing of Medical Device with Different Models
Replies
3
Views
2K
Julie O
J
M
2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation
Replies
2
Views
2K
missjenny
M
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