Next week I will be publishing a blog on the FDA regulatory pathway for medical devices, but today we are going to talk about what it means when you see the word "exempt." We also talk about the different types of exemptions:

The FDA established a risk-based device classification system for medical devices with Section 513 of the Food, Drug, and Cosmetic Act. Each device is assigned to one of three regulatory classes: Class I, Class II, or Class III. This classification is based on the level of control needed to ensure safety and effectiveness of medical devices.

As a device class increases from Class I, to Class II, and to Class III, the regulatory controls also increase.

All Class III devices require Pre-market Approval or a PMA.

Most Class II devices require a pre-market notification (i.e., 510k clearance).

Most Class I devices are exempt from pre-market notification. https://www.fda.gov/medical-devices/c...

There is also an exemption from the quality system requirements (i.e., 21 CFR 820), and there is an exemption from design controls.

If you want to learn more about how to conduct a regulatory pathway analysis for a medical device in the USA, including humanitarian device exemptions (HDE), please read our blog on the topic next week: https://medicaldeviceacademy.com/blog/