FD&C Act Section 513 - Device Classification

What it says

Medical devices are classified into one of three risk-based classes, Class I, II or III, with the applicable regulatory controls, general controls, special controls, or premarket approval, determined by the class assigned based on the device's risk to patients and the controls needed to provide reasonable assurance of safety and effectiveness.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Device classification determines which quality system and premarket requirements actually apply to a given device, so correctly identifying a device's classification is a foundational step that shapes the entire regulatory strategy around it.
• A device modification significant enough to change its intended use or technological characteristics can shift its risk profile in ways that call the original classification, and the controls built around it, into question.
• Because classification drives which premarket pathway applies, a device marketed under an incorrect classification can find itself out of compliance with premarket requirements even while its manufacturing quality system is otherwise sound.

What FDA inspectors look for

• Whether the device's current classification and associated regulatory controls match what is actually being manufactured and marketed.
• Whether device modifications made since original classification have been assessed for whether they affect the device's risk profile or classification.
• Whether special controls applicable to the device's class, where required, have actually been implemented as part of the quality system.

Related regulations