Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Eye Care Professional:
On May 22, 2009, the Food and Drug Administration (FDA) issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures, including laser-assisted in-situ keratomileusis (LASIK). This letter followed an April 2008, FDA Ophthalmic Devices Panel public meeting, at which the agency received information that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures.
The FDA continues to receive information concerning improper promotion and advertising practices by eye care professionals. The agency is writing again to eye care professionals to emphasize the importance of providing adequate risk information in their advertising and promotion of FDA‑approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed.
The FDA expects that this notice and the additional information that the agency is providing will permit eye care professionals to correct within 90 days of the date of this notice any advertisements or promotional materials that do not comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). After that time, the FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include warning letters, product seizures, injunctions and civil money penalty proceedings.
Lasers used in refractive procedures are restricted to sale, distribution, or use only upon authorization of a licensed practitioner or upon other conditions established by the FDA (21 U.S.C. §§ 360j(e) & 360e(d)(1)(B)(ii)). A restricted device is misbranded under the FD&C Act if its labeling or advertising is false or misleading (21 U.S.C. §§ 352(a) & 352(q)). In determining whether labeling or advertising is misleading, the FDA considers, among other factors, whether the labeling or advertising omits important information related to the device’s limitations and risks. (See 21 U.S.C. § 321(n)).
It is critical to disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the devices’ use. Advertisements and promotional materials that do not include appropriate risk information may be misleading.
Any person, including an eye care professional, who misbrands a restricted device through false or misleading advertising, or by causing the device’s labeling to be false or misleading, violates the FD&C Act and is subject to enforcement action.
The FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health. If you become aware of an advertisement, promotional material, or Internet promotion concerning any of these restricted devices that may be false or misleading, please forward it to CDRH’s Office of Compliance at the address listed above. Questions concerning this letter may be directed to Deborah Wolf, Regulatory Counsel, CDRH, Office of Compliance, at (301) 796-5732.
The FDA’s website contains a list of all FDA-approved lasers for refractive procedures, including lasers approved for LASIK. This site also provides information about the scope of the intended uses of each FDA-approved laser and the associated risks. Risk information may include side effects, warnings, precautions, and contraindications. Information about LASIK procedures and current FDA activities relating to LASIK can be found on FDA’s LASIK web site.
Sincerely yours,
Steven Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
