Zdrowie i gospodarka · 18.06.1997

Retaining Certain Preamendment Class III Devices in Class III

The Food and Drug Administration (FDA) is proposing to retain the following preamendment class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. Manufacturers of these referenced preamendment class III devices were requested, by an order published in the Federal Register, to submit a summary of, and a citation to, all information known or otherwise available to them respecting their devices, including adverse safety or effectiveness information concerning the devices that had not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA believes that these devices should remain in class III because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury. DATES: Submit written comments by September 16, 1997. FDA proposes that any final rule that may issue based on this proposal become effective 30 days after the date of publication of the final rule.