Medical Device and FDA Regulations and Standards News

Marcelo follows sandards closely. A link to his website is in all the threads he has posted in this forum. If you like, you can post Medical Device and FDA Regulations and Standards News, too. Just start a New Discussion (thread).


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Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit
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28
v9991
Marcelo Antunes
Informational US FDA – Historical Information about Device Emergency Use Authorizations
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34
Marcelo Antunes
Marcelo Antunes
Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program
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31
Marcelo Antunes
Marcelo Antunes
Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019)
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52
Marcelo Antunes
Marcelo Antunes
Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen
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74
Sidney Vianna
Marcelo Antunes
Informational US FDA issued the first warning letter for UDI violations to help ensure compliance
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64
Marcelo Antunes
Marcelo Antunes
Informational US FDA – Patient-Reported Outcomes (PROs) in Medical Device Decision Making
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29
Marcelo Antunes
Marcelo Antunes
Informational US FDA – Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples
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32
Marcelo Antunes
Marcelo Antunes
Informational US FDA – FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device
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29
Marcelo Antunes
Marcelo Antunes
Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices
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24
Marcelo Antunes
Marcelo Antunes
Informational US FDA Medical X-ray Imaging Devices guidances
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26
Marcelo Antunes
Marcelo Antunes
Informational US FDA Laser guidances
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24
Marcelo Antunes
Marcelo Antunes
Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
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37
Marcelo Antunes
Marcelo Antunes
Informational Fourth WHO Global Forum on Medical Devices REPORT
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27
Marcelo Antunes
Marcelo Antunes
Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature
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0
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32
Marcelo Antunes
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