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Zdrowie i gospodarka · 11.06.1997

General and Plastic Surgery Devices: Reclassification of the Tweezer-Type Epilator

The Food and Drug Administration (FDA) is proposing to reclassify the tweezer-type epilator from class III to class I when intended to remove hair. FDA also proposes to exempt this device from the premarket notification requirements. This reclassification is being proposed on the Secretary of Health and Human Services' own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).

Source: Federal Register — Food and Drug AdministrationOpen original release →