Stop Making ‘FDA Registration Certificates’: FDA

FDA says it has notified 25 companies they should stop producing and issuing “FDA registration certificates” that deceptively indicate FDA approval, clearance, or authorization for medical devices. CDRH Office of Regulatory Programs director Sean Boyd says the agency has seen an increase in the number of companies selling medical devices with certificates, including some that use the FDA logo.

“FDA does not issue any type of registration certificates to medical device establishments that register with the agency…,” Boyd says. “The Office of Regulatory Programs has alerted firms that produce and distribute these certificates that some device manufacturers and distributors are using registration certificates to create the misimpression that FDA has reviewed, approved, cleared, or authorized their products. FDA will continue to take appropriate steps to help ensure that the public is not misled about medical devices sold in the U.S.”