lowendahl.eu - News and information

lowendahl.eu - News and information

FDA plan to introduce ISO 13485 this fall

FDA/USA relatedPosted by Peter Feb 27, 2019 18:54:05
That FDA plan to change the QSR to follow ISO 13485 has been know for a while. The plan is to introduce this in the fall 2019. In a presentation made in December 2018 FDA points out that it will be a transition period partly because they need to trainbthe personnel but also that they need to revise the QSIT inspection handbook

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FDA issues labelling warning letters

FDA/USA relatedPosted by Peter Feb 27, 2019 18:12:36
Recently FDA have issued two similar warning letters based on promotion of products that are not cleared. In practise the companies get many different 483s because they do not have the documentation. Is this the beginnng of more strenghten control of labelling or just happen to be twice of these this month? Time will tell.
Here you find them imaging company and pouch manufacturer



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FDA CDHR Learn

FDA/USA relatedPosted by Peter Feb 26, 2019 08:03:01
FDA publish many guides but also training material online. They have several videos explaining the regulation and implementations but also PPt in all kind of subjects. At below link you find some of the material. A good starting point! Unfortunately they withdraw the gudie for small manufacturers with examples on how to meet QSR. This can howeveer be found at other placed.
https://www.fda.gov/training/cdrhlearn/?utm_source=Eloqua&utm_medium=email&utm_campaign=DICE%20Quarterly%20Newsletter%20-%20Vol.%201%20Issue%201



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