Medical Devices; Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and Gynecological Device
Information
Type
Rule
Regulated products
Medical Devices
Published
July 5, 2000
Last updated
July 5, 2000
Description
Document number 00-16808. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)