🌍 How to Use FDA Clearance in the Global Market

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2. 510(k) and PMA Are “Unlimited Certificates”

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• 510(k) clearance and PMA approval do not expire.

• They remain valid unless the device is withdrawn, significantly modified, or subject to enforcement action.

This makes them extremely useful as long‑term regulatory evidence when entering new markets.

 

3. Export Certificates = Global Evidence

 

FDA Export Certificates (CFG, COE, COE1) are widely accepted as:

• Proof of U.S. market authorization

• Confirmation of manufacturing compliance

• Evidence of device legitimacy for customs and regulators

Many countries explicitly request CFGs as part of registration.

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4. Key Elements in 510(k) or PMA Letters That Are Globally Useful

 

Foreign regulators often examine specific parts of the FDA decision letter and supporting documents. Beyond product name and intended use, the following elements are critical:

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🔑 4.1 Device Classification Information

Regulators often use FDA classification to determine:

• Local risk class

• Review depth

• Applicable conformity assessment route

 

Useful items include:

• FDA product code

• Regulation number (21 CFR)

• Device class (I/II/III)

• Review panel (e.g., cardiovascular, orthopedic)

These are often referenced in FDA resources on classification and premarket submissions.

 

🔑 4.2 Indications for Use (IFU) – Not Just Intended Use

Foreign regulators look closely at:

• Exact wording of indications

• Clinical claims

• Patient population

• Contraindications

• Use environment (home, hospital, professional)

A broader U.S. indication can support broader claims in new markets.

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🔑 4.3 Device Description and Technological Characteristics

 

510(k) summaries and PMA approval documents include:

• Key technological features

• Summary of pre-clinical test

• Energy sources

• Mechanisms of action

• Software/AI components

These help foreign regulators evaluate:

• Substantial equivalence

• Safety and performance

• Risk classification

This aligns with FDA’s emphasis on technological comparison in 510(k) reviews.

 

🔑 4.4 Substantial Equivalence (SE) Rationale (for 510(k))

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Many regulators accept the SE logic as evidence of:

• Benchmarking against a legally marketed device

• Demonstrated safety and performance

• Clinical relevance

The SE table in the 510(k) summary is often used as a shortcut for technical evaluation.

*please make sure that SE is also in subject market approved.

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🔑 4.5 Clinical Evidence (especially for PMA)

PMA approvals include:

• Clinical study summaries

• Safety and effectiveness data

• Post‑market surveillance requirements

Foreign regulators often rely on PMA clinical evidence to avoid requiring local trials.

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🔑 4.6 Manufacturing Site Information

Although not always in the decision letter, FDA records include:

• Establishment registration

• Device listing

• FEI number

Foreign regulators use this to verify:

• Legal manufacturer identity

• Production site legitimacy

• Compliance with FDA inspection requirements

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FDA verifies registration and listing during import/export processes.

 

🔑 4.7 V&V

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Since the US standárd is representing the art of the art. The testing needed by FDA would be easily accepted to use to  demonstrate either claim, specification, performance or safety requirement. 

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🔑 4.8 Post‑Market Requirements

Foreign regulators may request:

• PMA conditions of approval

• Post‑approval study requirements

• MDR/Vigilance history