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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
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Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
Sam Lazzara
Oct 9, 2013
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5
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45
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16,456
Jun 16, 2015
cmeby
Discussions
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IDE to support premarket submissions
bookish
Tuesday at 11:49 PM
Replies
0
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32
Tuesday at 11:49 PM
bookish
UDI for former manufacturer - My company is a distributor
BLoganB
Dec 5, 2018
Replies
0
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66
Dec 5, 2018
BLoganB
D
Design developer - 21 CFR 807 - do we need to register?
Daliane
Dec 3, 2018
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0
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37
Dec 3, 2018
Daliane
FDA News
FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program
Marcelo Antunes
Nov 26, 2018
Replies
0
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61
Nov 26, 2018
Marcelo Antunes
Medical Device News
FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
Marcelo Antunes
Nov 26, 2018
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0
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44
Nov 26, 2018
Marcelo Antunes
Attachment browser
Medical Device News
Medical Device Enforcement and Quality Report
Ajit Basrur
Nov 25, 2018
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1
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100
Nov 26, 2018
supadrai
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IFUs with promotional labeling
newerdeviceguy
Nov 14, 2018
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0
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64
Nov 14, 2018
newerdeviceguy
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How does the FDA count violations of, for example, misbranding? (Medical Devices)
supadrai
Nov 12, 2018
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1
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81
Nov 12, 2018
Al Rosen
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Examples of Pre-Sub, SRD, PMA Shells and Templates
ablasina
Nov 6, 2018
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3
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93
Nov 6, 2018
ablasina
Medical Device News
FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
Marcelo Antunes
Nov 2, 2018
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0
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83
Nov 2, 2018
Marcelo Antunes
Medical Device News
FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices
Marcelo Antunes
Nov 2, 2018
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0
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110
Nov 2, 2018
Marcelo Antunes
Medical Device News
FDA Withdrawals Two Proposed Rules
Marcelo Antunes
Oct 31, 2018
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0
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87
Oct 31, 2018
Marcelo Antunes
Medical Device News
FDA news 14-09-18 - Recognition and Withdrawal of Voluntary Consensus Standards
Marcelo Antunes
Sep 14, 2018
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2
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177
Oct 30, 2018
Marcelo Antunes
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Validation of DocuSign within QMS
chenardj1
Oct 15, 2018
Replies
1
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111
Oct 30, 2018
yodon
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Medical device mobile app UDI - Where is the UDI labelled?
snoopy2017
Oct 26, 2018
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1
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95
Oct 30, 2018
DEVigil
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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