Who owns the 510(k)?
Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).
Donawa
Maria E
ME
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D018795:Device Approval; D040541:Marketing / Q000331:legislation & jurisprudence*; D010067:Ownership / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration