# Obstetric and Gynecology Devices; Effective Date of Requirement for Premarket Approval for Glans Sheath Devices
> **Food and Drug Administration** · Final rule. · Published 2002-06-14 · Effective 2002-06-14 · 67 FR 40848
## Document
- **Document number:** 02-15042
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 40848
- **CFR reference:** 21 CFR 884
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/06/14/02-15042/obstetric-and-gynecology-devices-effective-date-of-requirement-for-premarket-approval-for-glans)
---
*AI Analytics · CC0 1.0*