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On March 3, 2021, FDA issued a statement acknowledging that certain
entities produce certificates of registration for medical device
manufacturers and clarifying that the agency does not issue such
certificates. The agency also announced that it sent letters to 25
entities demanding that they stop producing these false and
misleading certificates because some device manufacturers and
distributors are using them to claim that the devices they produce
or sell are cleared, approved, or otherwise authorized by FDA. It
is important to add that FDA likewise does not issue certificates