Obstetric and Gynecology Devices; Effective Date of Requirement for Premarket Approval for Glans Sheath Devices
fda-device · Food and Drug Administration · Rule · Published 2002-06-14 · Effective 2002-06-14 · 67 FR 40848
Document
Document number
02-15042
Federal Register citation
67 FR 40848
CFR reference
21 CFR 884
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2002-06-14
Effective date
2002-06-14
HHS docket
Docket No. 99N-0922
Abstract
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 glans sheath medical devices. The agency has previously published its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices.