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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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FAQs
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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17,063
Jun 16, 2015
cmeby
Discussions
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Control of Promotional/Advertising Materials
tebusse
Mar 14, 2018
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8
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675
Today at 12:26 PM
Jnks_Meddev
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510(k) expanding the indication for use for a cleared device
katiesam
Tuesday at 8:06 AM
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6
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69
Yesterday at 12:26 PM
katiesam
M
Demonstrating battery safety in 510(K) submission for the FDA
Mark Meer
Feb 12, 2014
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8
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1,640
Tuesday at 6:28 PM
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Medical Device Manufacturer vs. Specification Developer
SylvieS
Jan 23, 2018
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941
Feb 11, 2019
EBD
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How to write a US FDA proof MDR procedure?
Arnthor
Apr 25, 2011
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3,273
Jan 23, 2019
Jean_B
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21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing
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Jan 9, 2019
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Jan 10, 2019
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Letter to file vs Special 510 for additional accessory in orthopaedic kit
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Oct 10, 2018
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Jan 3, 2019
Chrisx
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Substantial Equivalence Predicate Device Testing
kellascat
Dec 19, 2018
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1
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101
Dec 19, 2018
supadrai
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IDE to support premarket submissions
snoopy2017
Dec 11, 2018
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66
Dec 11, 2018
snoopy2017
UDI for former manufacturer - My company is a distributor
BLoganB
Dec 5, 2018
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112
Dec 5, 2018
BLoganB
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Design developer - 21 CFR 807 - do we need to register?
Daliane
Dec 3, 2018
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81
Dec 3, 2018
Daliane
FDA News
FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program
Marcelo Antunes
Nov 26, 2018
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113
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
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Nov 26, 2018
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103
Nov 26, 2018
Marcelo Antunes
Medical Device News
Medical Device Enforcement and Quality Report
Ajit Basrur
Nov 25, 2018
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156
Nov 26, 2018
supadrai
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IFUs with promotional labeling
newerdeviceguy
Nov 14, 2018
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99
Nov 14, 2018
newerdeviceguy
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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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