mdi Consultants
New guidance documents for Glasses and Spectacles
If you are an exporter or importer of sunglasses or prescription spectacles, please take note of the new FDA guidance documents.
For all companies that have their products listed under the following codes:
886.5844 (HQG) Prescription Spectacle Lens
886.5842 (HQZ) Spectacle Frames
886.5850 (HQY) Sunglasses
886.5840 (HOI) Magnifying Spectacles
Please be aware of the following:
The United States Food and Drug Administration (USFDA) would like to inform you that on September 2, 2010, USFDA issued the following guidance:
Guidance for Industry and FDA Staff – Impact-Resistant Lenses: Questions and Answers.
This guidance is a revision of “Impact-Resistant Lenses: Questions and Answers (FDA 87-4002),” issued September 1987. This guidance updates answers to questions that industry and consumers frequently ask FDA about impact-resistant lenses and FDA regulation of eyewear.
The FDA guidance can be found at: Guidance for Industry and FDA Staff – Impact-Resistant Lenses: Questions and Answers