Guidance Documents (Medical Devices and Radiation-Emitting Products) Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers

Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers

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Document issued on: September 2, 2010
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070755.pdf

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Division of Small Manufacturers, International and Consumer Assistance
Office of Communication, Education, and Radiation Programs

Contains Nonbinding Recommendations
Preface
Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Alternatively, e lectronic comments may be submitted to http://www.regulations.gov. When submitting comments, please refer to Docket No. FDA-2007-D-0367. Comments may not be acted upon by the Agency until the document is next revised or updated.


Additional copies are available You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number (23) to identify the guidance you are requesting.

Table of Contents

* Introduction
* Overview
* Prescription and Non-Prescription Glass Lenses
* Prescription and Non-Prescription Plastic Lenses
* Finished Lenses
* Lens Blanks (Semi-Finished Lens)
* Plano (Non-Corrective) Lens
* Sunglasses
* Novelty and Children's "Toy" Sunglasses
* Other Lens Types
* Who Should Test and When
* Testing Apparatus and Procedure
* Sampling Plans
* Records
* Exemptions
* Importing Lenses, Eyeglasses, and Sunglasses
* Retail Stores and Optical Laboratories
* Dispensing Untested Lenses
* Frames and Designs
* Labeling
* Additional Regulatory Requirements
* Consumer Information
* APPENDIX A. 21 CFR 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
* APPENDIX B. Photograph of Drop Ball Test Unit (Impact Tester)
* APPENDIX C. Certification Statement of Impact Resistance


Guidance for Industry and FDA Staff
Impact-Resistant Lenses:
Questions and Answers
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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Guidance Documents (Medical Devices and Radiation-Emitting Products) Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers