FDA – the U.S. authority for medical-device oversight

The Food and Drug Administration (FDA) is the federal agency that clears and controls medical devices and in-vitro diagnostics for the U.S. market. All requirements are defined in Title 21 of the Code of Federal Regulations (CFR), covering classification, pre-market submissions, GMP obligations and duties for foreign manufacturers.

The U.S. three-class device classification system

FDA assigns products to Class I, II or III, depending on their risk.
Class I covers low-risk items (basic surgical instruments), Class II medium-risk products (e.g. diagnostic kits, infusion pumps) and Class III the highest-risk, life-supporting or life-sustaining devices (implantable defibrillators, heart valves).

Many Class I and some Class II devices are exempt from pre-market submission, yet manufacturers must still complete Establishment Registration and Device Listing.

Premarket submission pathways – 510(k), PMA and De Novo

FDA offers three main routes to U.S. market access:

510(k) – Premarket Notification for devices substantially equivalent to an existing predicate; typical for Class II.
PMA – Premarket Approval: a full scientific review for Class III and novel high-risk devices with no predicates.
De Novo – for new low- to medium-risk devices without a predicate and not appropriate for PMA.

Choosing the right pathway depends on device class, predicate availability and FDA’s interpretation of technological and clinical equivalence.

Establishment registration and device listing

Every domestic or foreign manufacturer must enrol in FDA’s Establishment Registration database (FURLS) and renew annually between 1 October and 31 December. Each marketed device must also be entered in the Device Listing database with the correct product code and classification name.
These records enable FDA to schedule inspections and verify market information; outdated or inconsistent data can trigger suspension.

Role of the U.S. Agent for foreign manufacturers

Non-U.S. producers must appoint an in-country representative – the U.S. Agent – who:

acts as the primary contact for registration matters,
responds to FDA questions on devices and inspections,
co-ordinates import, complaint and post-market actions.

Without a named U.S. Agent, Establishment Registration and Device Listing cannot be completed.

QSR requirements and FDA inspections

Manufacturers are obliged to comply with the Quality System Regulation (21 CFR 820) – the U.S. equivalent to ISO 13485, with several unique clauses. FDA may conduct unannounced inspections worldwide; both the producer and the U.S. Agent must grant immediate access to facilities and documentation. Findings may result in a Form 483 or a Warning Letter.

IVD devices under FDA regulations

IVDs follow the same legal framework but are specifically covered by 21 CFR 809. Classification depends on intended use, user type (professional vs. OTC) and diagnostic-error risk.
FDA places strong emphasis on analytical and clinical-performance data: sensitivity, specificity, LoD, matrix effects. A 510(k) must usually include full study results and a comparison with a predicate. Novel or high-risk tests require PMA. Labels must comply with §809.10 (intended use, limitations, warnings, IFU).

Maintaining regulatory compliance

After authorisation the obligations continue. Any significant design, composition, IFU or quality-system change may trigger a new 510(k), a PMA supplement or a Device-Listing update. Manufacturers must also file MDR adverse-event reports and run post-market surveillance. Failure to notify changes or address inspections can lead to product withdrawal.

How Pure Clinical supports U.S. medical-device and IVD registrations

FDA tolerates no shortcuts. Pure Clinical guides companies through every step:

confirming device class and predicate availability,
selecting and preparing the correct 510(k), De Novo or PMA dossier,
handling Establishment Registration and Device Listing in FURLS,
facilitating the selection and co-ordination of the U.S. Agent,
benchmarking the quality system against QSR and inspection readiness,
running pre-submission audits and gap analyses.

Whether you are entering the U.S. for the first time or managing changes to an existing portfolio, Pure Clinical ensures a compliant, predictable FDA pathway.

FAQ

Are EU-certified devices automatically accepted by the FDA?

No – the FDA does not automatically recognize CE certification or MDR compliance. Even if a product has EU market approval, it must undergo full FDA classification and submission procedures. However, EU clinical data may be used as supportive documentation—if aligned with FDA standards—potentially accelerating review.

What are the most common reasons for 510(k) rejection by the FDA?

Typical reasons include: insufficient comparison data with the predicate device, incomplete validation reports, inconsistencies between IFU and intended use, and misinterpretation of risk classification. The FDA places high importance on data consistency and clearly defined indications for use.

Can a single U.S. Agent represent multiple foreign manufacturers?

Yes, provided they have the organizational capacity, regulatory experience, and product-specific knowledge for each represented entity. The FDA may challenge the agent’s adequacy if they fail to respond to inquiries or lack access to documentation. In practice, choosing an agent based solely on cost is discouraged.

Does every update to the Instructions for Use (IFU) require resubmission to the FDA?

Not every update – changes related to formatting or minor language edits typically do not require resubmission. However, any update affecting indications, warnings, use instructions, or the intended user population must be reported, either through a 510(k) amendment or a new submission, depending on the change’s impact.

US FDA Registration for Medical Devices & IVDs