FDA Compliance
FDA Registration
Mandatory For Medical Device Manufacturers
Applies to: Domestic and foreign device establishments
What Is FDA Registration and Why It Matters?
FDA Registration is mandatory for medical device manufacturers, foreign manufacturers, initial importers, contract manufacturers, and companies involved in repackaging, relabeling, or specification development of devices intended for the U.S. market. Both domestic and foreign facilities must register with the FDA annually and list all devices they manufacture or distribute. Registration does not constitute FDA approval or clearance of a device, but it is a legal prerequisite for market entry and must be completed before a device can be commercially distributed in the United States. Failure to register or maintain an active registration can result in serious legal consequences, including import alerts, warning letters, and seizure of products.
How Can We Help?
At Certilance, we simplify the FDA registration process for both domestic and international manufacturers. We ensure your establishment and device listings are accurately completed and submitted through the FDA Unified Registration and Listing System (FURLS), and that your registration is renewed on time each year. Whether you are registering for the first time or managing an existing registration, our consultants make sure your records are complete, up to date, and fully compliant with FDA requirements, so your products can reach the U.S. market without unnecessary delays.
FAQ
FDA Registration — frequently asked questions
Yes. Medical devices must obtain FDA clearance or approval before being marketed in the United States. The pathway depends on device classification, intended use, and risk profile.
The U.S. Food and Drug Administration (FDA) regulates devices through:
- 510(k) premarket notification
- De Novo classification
- Premarket Approval (PMA)
Each pathway has different evidence, testing, and review requirements.
No. CE marking and FDA approval are completely separate regulatory systems. Compliance with one does not grant access to the other market.
FDA does not formally certify ISO standards. However, an ISO 13485-aligned quality system strongly supports FDA Quality System Regulation (QSR) compliance and significantly reduces inspection findings.
Certilance helps manufacturers prepare documentation, quality systems, and regulatory evidence aligned with FDA expectations, ensuring submissions and inspections proceed efficiently.
FDA timelines vary by pathway (510(k), De Novo, or PMA) and submission quality. While FDA review periods are defined, real-world timelines are often extended due to deficiency letters, additional data requests, or design control gaps.
Early regulatory alignment significantly reduces delays.
FDA-related costs depend on:
- Regulatory pathway
- Testing and validation requirements
- Submission complexity
- FDA user fees (where applicable)
Well-structured submissions reduce review cycles and overall cost exposure.
FDA Registration
Ready to start your FDA Registration project?
Book a free consultation and we will map the gaps, the timeline and the cost before any work begins.