GUIDANCE DOCUMENT
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses - Guidance for Industry April 2000
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.