His characterization is not quite accurate. FDA does not certify it; rather, the company building the medical device certifies to the FDA that it has been properly validated for use and the FDA accepts their validation.<p>Trust in the company&#x27;s ability to properly validate the device is tempered by regular FDA (and other regulatory bodies) audits of their development process and process data, test reports and a general desire to stay in business. FDA can and will take your product off the market if it appears to be unsafe and the company does not respond appropriately.