Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
October 4, 2007
Last updated
October 4, 2007
Description
Document number E7-19580. The Food and Drug Administration (FDA) is proposing to amend the classification regulation for the electrocardiograph electrode device to establish special controls and to exempt the device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act). The agency is taking this action on its own initiative. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control for the device if the rule is finalized. The agency believes that special controls, when followed and combined with the general controls, will provide reasonable assurance of the safety and effectiveness of these devices, if this proposal becomes final.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)