Class I II Exemptions | 合法醫療器材資訊網

Most Class I and Class II[1] devices are exempt from premarket notification [510(k)][2] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the Quality System (QS) Regulation[3].

A class I or class II device that is exempt from 510(k) requirements must still comply with other requirements (known as regulatory controls[4]) unless the device is expressly exempt from those requirements as indicated in the regulation for that device type.

To determine whether a device is exempt from 510(k) or GMP requirements, search the FDA’s Product Classification database[5].

Most class I and some class II devices are exemp...