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PDF Printer VersionDocument issued on: September 2, 2010

This document supersedes Impact-Resistant Lenses: Questions and Answers, September 1987.

The draft of this document was issued on October 26, 2007.

For questions regarding this document contact John Stigi at 301-796-5848 or john.stigi@fda.hhs.gov.

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

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

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.

62. Q. Are eyeglasses and sunglasses safe to use for sports?

A. No. You should wear sports goggles that meet appropriate safety standards for the sport. You should not wear sunglasses or eyeglasses as personal protective equipment for sports or in situations requiring industrial safety lenses that could result in an impact to the face.

63. Q. Where can consumers report serious injuries related to medical devices?

A. Consumers may voluntarily report device-related deaths, injuries, and product problems to the Medical Device Reporting Office (MEDWATCH) of FDA. Consumers should use the MedWatch FDA Voluntary Form 3500 available on the Internet at http://www.fda.gov/Safety/MedWatch/default.htm to report problems. For information about a medical product, please call 1-888-INFO-FDA (1-888-463-6332). Written correspondence may be mailed to:

MedWatch

5600 Fishers Lane

Rockville, MD 20852-9787

APPENDIX A.

21 CFR 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.410

 APPENDIX B.

Photograph of Drop Ball Test Unit (Impact Tester)

APPENDIX C.

Certification Statement of Impact Resistance


1 The Federal Hazardous Substances Act regulations in 16 CFR 1500.3(a)(1), defines "Act" as the Federal Hazardous Substances Act (Pub. L. 86-613, 74 Stat. 372-81 (15 U.S.C. 1261-74)), and amendments to such Act.

    

SOURCE

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