FDA Exemptions CLASS II

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FDA Exemptions CLASS II

FDA EXEMPTS ADDITIONAL CLASS II MEDICAL DEVICES FROM PRE-MARKET NOTIFICATION (510(K))

Federal Register announcement, effective January 21, 1998, listed Class II devices, subject to special limitations, that are now exempt from the pre-market notification requirements under the Food and Drug Administration Modernization Act of 1997. The FDA will take comments within 90 days and after review consider whether the list should be modified. A total of 62 in vitro diagnostic and medical devices were given exemption.

The exemption from the requirements of pre-market notification for a generic type of device listed in the FDA document, applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. The FDA has listed 3 reasons for when the listed device would not be exempted from the pre-market notification requirement.

the intended use is different from the legally marketed generic device
the device operates using a different fundamental scientific technology than the legally marketed device in that generic type
is an in-vitro device: that is intended for use in the diagnosis, monitoring or screening of neoplastic diseases with the exception of immunohistochemical devices; etc.( there are several other exemptions for in vitro diagnostic devices)

The FDA did have one limitation to the exemption from the pre-market notification and that was to the Biofeedback device. The exemption was limited to only the prescription battery powered devices that are indicated for relaxation training and muscle reeducation and prescription use.

For more information on this exemption and a copy of the list please use our inquiry page, or go to the FDA website at, http://fda.gov/cdrh/fedregin.hmtl