Guide to FDA 510(k) Labeling and Instructions for Use (IFU)

Your device labeling is not just marketing material; it's a critical component of your 510(k) submission that is legally binding and heavily scrutinized by the FDA. Inconsistent or incomplete labeling is a common reason for an Additional Information request. All labeling must comply with FDA regulations, primarily 21 CFR 801.

What Does "Labeling" Include?

The term "labeling" is broad and covers all written, printed, or graphic matter accompanying your device. For a 510(k), you must submit a complete, final draft of all labeling, including:

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  Device Labels: The physical labels affixed to the device itself and its packaging.
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  Instructions for Use (IFU): A detailed booklet or manual explaining how to use the device safely and effectively. This is the most extensive part of the labeling.
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  Package Inserts: Any additional documentation included in the packaging.
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  Patient Labeling: If applicable, simplified instructions intended for the patient.

Key Requirements for the Instructions for Use (IFU)

The IFU is a comprehensive technical document. It must be clear, concise, and written for the intended user (e.g., a surgeon, a lab technician, a patient).

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  Indications for Use: Must be an *exact* match to the Indications for Use statement submitted elsewhere in your 510(k).
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  Device Description: A brief explanation of the device and its principle of operation.
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  Contraindications: A clear statement of situations where the device should not be used.
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  Warnings and Precautions: Warnings describe potential serious adverse events, while precautions describe measures to take to avoid device malfunction or damage.
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  Step-by-Step Instructions: Detailed, unambiguous directions for setup, use, cleaning, and storage.
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  Technical Specifications: Any relevant performance specifications the user needs to be aware of.

The Unique Device Identification (UDI) System

Your device label must comply with the FDA's UDI system. The UDI is a unique numeric or alphanumeric code that consists of two parts:

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  Device Identifier (DI): A mandatory, fixed portion that identifies the labeler and the specific version or model of a device.
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  Production Identifier (PI): A conditional, variable portion that can include the lot/batch number, serial number, expiration date, or manufacturing date.

The UDI must be presented in both a plain-text version and a machine-readable format (e.g., a barcode or QR code). Your 510(k) submission must include a draft label showing the UDI in its final format.