Tag: device claims

device claims

Regulatory/FDA

FDA Cracks Down on “FDA-registered” Device Certificate Claims

FDA Cracks Down on “FDA-registered” Device Certificate Claims

March 29, 2021 – The FDA does not issue certificates to medical device companies that register their facilities with the agency, nor does the registration of a device facility denote that products made in that facility are approved, cleared or authorized by the FDA, so a recent increase in the number of companies selling devices […]

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