Medical Device Design and Regulation

12.

Labeling and Instructions for Use

12.1.

Regulatory Requirements for Labeling

12.1.1.

FDA Labeling Requirements

12.1.2.

EU MDR Labeling Requirements

12.2.

Content of the Instructions for Use

12.2.1.

Intended Use and Indications

12.2.2.

Contraindications

12.2.3.

Warnings and Precautions

12.2.4.

Instructions for Use

12.2.5.

Maintenance and Storage

12.3.

Symbols for Medical Device Labeling

12.3.1.

Commonly Used Symbols

12.3.2.

Interpretation and Application

12.4.

Unique Device Identification

12.4.1.

UDI System Structure

12.4.2.

Labeling Requirements

12.4.3.

Database Requirements

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11. Regulatory Submission Pathways

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13. Post-Market Surveillance and Activities