FDA US Medical Device Registration

Medical device manufacturers must implement a quality management system that fulfills the requirements of FDA's Quality Management System Regulation (QMSR), which applies from February 2, 2026. The US FDA does not recognize ISO 13485 certificates even though QMSR aligns closely with ISO 13485. However, FDA is a participant of the Medical Device Single Audit Program (MDSAP).

Medical device classification in the US is based on substantial equivalence. You must find a legally marketed device cleared for sale by the FDA that is substantially equivalent to your own, called a predicate. Substantial equivalence is determined based on a range of factors, but mostly your device’s intended use and indications for use. Your device’s classification will match the classification of your predicate.

The US FDA De Novo process is a regulatory pathway for novel devices (i.e., devices not substantially equivalent to any legally marketed devices) that are low or moderate risk. To qualify for the De Novo process, you must demonstrate that your device is lower risk and has no predicate. Novel devices that do not qualify for the De Novo process are ruled Class III and must follow the Pre-Market Approval (PMA) submission pathway.

All medical device manufacturers and related facilities are required to pay an annual establishment registration fee to US FDA of USD 11,423 per facility.

For devices requiring 510(k) premarket notification, the applicable review fees are:

• Standard 510(k) review: USD 26,067 per submission
• Small business 510(k) review: USD 6,517 per submission

For devices submitted under the De Novo classification pathway, the review fees are:

• Standard De Novo review: USD 173,782 per submission
• Small business De Novo review: USD 43,446 per submission

All fees listed are government fees only and do not include consulting services, dossier preparation, testing, or regulatory representation. Fees may change without notice.

Check our Fee Calculator for up-to-date government fees in 14 markets.

Pure Global offers flat-fee annual pricing for U.S. Agent and FDA establishment registration services, starting at $1,000/year per listing. The flat fee includes acting as your U.S. Agent, FDA establishment registration, official correspondent duties, and support with processing your annual FDA establishment fee. It does not include the FDA government fees themselves or premarket submissions such as 510(k) or PMA, which are quoted per project. Use our Fee Calculator for an instant estimate.