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A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…
Added by Compliance4all on November 11, 2016 at 4:39am — No Comments
A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.
Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.…
Added by Compliance4all on October 26, 2016 at 5:59am — No Comments
Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.
Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…
Added by Compliance4all on October 20, 2016 at 5:59am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on January 21, 2010 at 8:47am — No Comments
Added by CC-Conrad Clyburn-MedForeSight on March 2, 2009 at 3:30pm — No Comments
Added by CC-Conrad Clyburn-MedForeSight on December 17, 2008 at 5:59pm — No Comments