FDA Guidance - Impact Resistant Lenses - Q and A

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Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers 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. As you read through the guidance, you'll find quite a number of useful hyperlinks to additional information and references.

Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410. This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.

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 revision reflects the exemption of sunglasses from the Premarket Notification (510(k)) requirement effective February 19, 1998 (21 CFR 886.5850(b)). The revised document also includes a more detailed discussion about lens blanks, semi-finished, finished, and plano lenses, as well as import procedures. The terms "eyeglasses" and "spectacles" are used interchangeably in this document.

Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority of the general public. FDA believes that impact-resistant lenses are an essential component of the safe design of these devices.  The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR 801.410.

For more information on this topic, contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) by phone at 1-800-638-2041, by fax at 301-847-8149, by e-mail at dsmica@fda.hhs.gov, or write to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Ave.
WO66-4613
Silver Spring, Maryland 20993

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HIV AIDS - Gene Research Shows Promise

Jay Levy of UCSF wrote a recent editorial in the NEJM (Levy, NEJM, 2/12/09), as reported in this Medical News Today article, New HIV/AIDS Research Directions Show Promise, NEJM Editorial Says. This is the first time I've read about this, and find it incredibly fascinating and exciting. Here are my takeaways from reading the article . . .

1. Recent HIV/AIDS research that examines the role certain genes play in inhibiting HIV progression shows promise for the development of new treatment measures
2. HIV enters the body through CD4+ T cells and then binds to the chemokine receptors CCR5 and CXCR4.
3. Research has found that people whose cells lack expression of the CCR5 gene typically demonstrate resistance to the virus.
4. Researchers examined the case of an HIV-positive patient with myelogenous leukemia who received a bone marrow transplant from a person whose cells lacked expression of the CCR5 gene. After two transplants, the researchers determined that the patient had no leukemia recurrence and no detectable level of HIV in the bloodstream
5. Levy says, "the result of this study [reported in the same NEJM issue] and others provide further encouragement for those examining approaches to treatment that reduce CCR5 [receptor] expression in persons with HIV." This is the study Levy refers to, Brief Report: Long-Term Control of HIV by CCR5 Delta32/Delta32 Stem-Cell Transplantation (summary).

Related Posts: 

CDC Adopts 2 New HIV Intervention Approaches
HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
HIV AIDS Bone Marrow Transplant Cure - Skeptical View
HIV Treatment Goes Bionic
HHS Updates HIV Treatment Guidelines (free pdf)

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