FDA US Medical Device Registration

US medical device registration: build the right sequence

The US Food and Drug Administration regulates medical devices and IVDs. CDRH oversees most devices; CBER regulates certain device categories. The term “FDA registration” can describe establishment administration, but it must not be confused with a device’s marketing authorization.

Use the FDA device-regulation overview to define the applicable requirements. Pure Global can support pathway assessment and implementation; FDA makes the regulatory decision. No consultant can ensure approval.

Classification and pathway comparison

Start with a written classification and product-code rationale. Class I does not mean registration alone, Class II does not always mean 510(k), and novelty does not automatically mean PMA. Intended use, technology and the actual regulation determine the requirements.

Evidence and FDA interaction

Map each claim and risk to the required evidence: bench performance, biocompatibility, sterility, electrical safety, software, cybersecurity, usability, clinical data or IVD performance as applicable. Confirm the tested and marketed configurations. For body-contacting devices, the FDA biocompatibility and ISO 10993 guide explains risk-based endpoint assessment, representative test articles and the 2025 edition's partial recognition. Use a focused Pre-Submission/Q-Sub before committing to a costly uncertain evidence strategy.

Prepare covered 510(k) and De Novo submissions in eSTAR, subject to applicable exemptions. Distinguish the template from the receiving center’s delivery channel. Template completion does not establish that the scientific evidence supports the device.

Quality system, local roles and launch readiness

QMSR has applied since February 2, 2026 and incorporates ISO 13485:2016 with FDA-specific provisions. An ISO certificate alone does not replace compliance or FDA inspection authority.

Assess each establishment’s activities for registration, listing and annual fees. Foreign establishments subject to registration appoint a US Agent; the official correspondent and initial importer are distinct roles. Confirm account access, consent, urgent communications and complaint escalation in the relevant agreements.

Before supply, reconcile the authorization, models, labels, UDI obligations, establishment/listing records and importer arrangements. Maintain release evidence and distribution traceability. After launch, implement Medical Device Reporting, complaint investigation, corrections/removals assessment and change control. Our Form 483 response guide covers inspection observations and remediation; the CFG guide covers eligible export certificates.

Government fees and realistic timelines

For FY 2027, October 1, 2026–September 30, 2027, the FDA fee schedule lists an annual establishment fee of US$13,785, a standard 510(k) fee of US$28,653 and a standard De Novo fee of US$191,020. Reduced submission fees require a qualifying small-business determination; annual establishment-fee hardship waivers have separate conditions and exclude initial registration.

Government fees, consultant fees and evidence-generation costs are separate. A review-day goal excludes some applicant work and is not a guaranteed calendar launch date. A useful project estimate identifies the pathway, available evidence, missing tests, submission work, authority review and response allowance. Use our pricing information to discuss the service scope, then maintain a dated device-specific execution plan.