As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.
If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.
If you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules.
