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

The Food and Drug Administration (FDA) is issuing a final rule to reclassify the tweezer-type epilator from class III (premarket approval) to class I (general controls) when intended to remove hair. FDA is also exempting this device from the premarket notification (510(k)) requirements. This action is taken 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), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: This regulation is effective November 25, 1998. FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090.