Meeting FDA Compliance Standards in printing Class I, Class II and Class III Devices

TouchMark’s expertise includes medical device pad printing in multiple categories of FDA classification. Since 1976, the FDA has classified medical devices as Class I, Class II, and Class III based on the risk posed by the device.

• Class I: General Controls. The FDA classifies Class I medical devices as low-risk to consumers. The FDA subjects Class I products to general controls aimed at establishing ongoing “safety and effectiveness” after devices are approved to market. General controls include the maintenance and evaluation of manufacturing, reporting, registration and record-keeping processes.
• Class II: General Controls with Special Controls. The FDA has determined Class II medical devices to present a greater risk to consumers than those categorized as Class I. The FDA applies the same General Controls to Class II medical devices as Class I. They also enforce additional Special Controls related to labeling, performance standards, and testing requirements.
• Class III: General Controls and Premarket Approval. The highest medical device category is Class III. The FDA will classify medical devices as Class III if they “support or sustain life, are implanted in the body, or have the potential for unreasonable risk of illness or injury.” Because Class III devices pose the highest risk to consumers, these devices endure a higher standard for approval, including proof of safety and effectiveness. These products are subject to the same controls as Class I and Class II medical devices and require premarket approval.

You can rely on TouchMark to ensure your product meets the FDA’s compliance standards for printing on Class I, Class II and Class III medical devices.