FDA Medical Device Establishment Registration

FDA Medical Device Registration requires establishments involved in the production, marketing, or distribution of medical devices intended for use within the United States to register with the FDA annually through Establishment Registration, in accordance with 21 CFR 807. Foreign establishments must also designate a US Agent for official communication with the FDA.

Medical devices are classified based on a rule-based risk classification system into three risk classes, from lowest risk to highest risk Class I, Class II, Class III. The registration process for the three classes varies for certain Class II devices and all Class III devices require a pre-market assessment notification of 510k.