Issue Date: April 9, 2000
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses – Guidance for Industry
This guidance document is intended to provide guidance for rigid gas permeable (RGP) contact lens manufacturers that submit marketing applications for contact lenses intended for use as orthokeratology devices. A large segment of the document is devoted to a labeling template that includes the primary package, a package insert, a practitioner fitting guide and a two part patient booklet. Detailed examples of specific labeling components required by regulation are provided. A primary goal of the labeling is to communicate reasonable expectations of success to the user.
Download the Guidance Document
