What’s the difference between FDA listing and registration?
FDA registration identifies an establishment and the medical-device activities performed there, while device listing identifies the devices connected with that establishment. Neither registration nor listing means that the FDA has approved, cleared, certified, or endorsed the company or device.
Answer
Establishment registration and device listing are related but separate FDA requirements under 21 CFR Part 807.
Establishment registration records information about a physical facility involved in manufacturing, sterilizing, repackaging, relabeling, remanufacturing, importing, or performing another regulated device activity. Each qualifying establishment must register separately and renew its registration annually.
Device listing identifies the medical devices manufactured or processed at the establishment. Listing information may include the product code, proprietary names, establishment activities, and the associated 510(k), De Novo, PMA, HDE, or other premarket-submission number when one is required. Exempt devices may be listed using their product code without a premarket-submission number.
The annual user fee is generally charged for each registrable establishment, not for each individual device listing. However, separate premarket-submission fees may apply to 510(k), De Novo, PMA, and other applications.
Registration answers, “Which regulated facility is performing this activity?” Listing answers, “Which devices are connected to that facility and activity?” Manufacturers may have multiple registered facilities associated with the same listing, while a facility may be associated with numerous device listings.
FDA expressly states that an entry in its registration and listing database does not denote authorization. Companies should therefore avoid phrases such as “FDA registered product” when they could mislead customers into believing that registration represents clearance or approval.
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