Intraocular lenses for children in the year 2000: when is oversight by the institutional review board or food and drug administration required?

ew pediatric ophthalmic surgeons, in the year 2000, would argue with the assertion that intraocular lens (IOL) implantation in children is within the standard of care. In fact, IOL implantation has become the most common method used to correct aphakia in children overall. Controversy still exists when treatment involves certain subsets of the pediatric population, such as neonates or those with juvenile rheumatoid arthritis, inadequate capsular or zonular support, or severe microphthalmia. With these exceptions, IOL use in children has become commonplace and has included the use of market-approved lenses made from polymethylmethacrylate, acrylic, and silicone materials. However, based on frequent inquiries I receive from pediatric ophthalmologists throughout the United States, confusion remains about whether IOL implantation in children is investigational. Also, confusion still exists about the Food and Drug Administration (FDA) rules as they apply to IOL implantation in children. The following information should be read carefully by each IOL surgeon and shared with the Institutional Review Board (IRB) responsible for oversight at the facility where these implantations occur. The FDA Division of Ophthalmic Devices has reviewed the text of this editorial to make certain that it conforms with current guidelines. Because IOLs are market approved by the FDA only for the elderly, implantation in a child is considered “offlabel.” The FDA is clear on when IRB approval is required for off-label use of a medical device. A September 1998 publication, which appears on the FDA’s Web site (http:// www.fda.gov/oc/oha/IRB/toc8.html#FAQ) and is entitled, “Guidance for Institutional Review Boards and Clinical Investigators,” gives answers to frequently asked questions about IRB review for medical devices. Question No. 7 reads, “Does FDA require IRB review of off-label use of a marketed device?” The answer is, “YES, if the off-label use is part of a research project involving human subjects. NO, if the off-label use is intended to be solely the practice of medicine, i.e., for a physician treating a patient and no research is being done.” Furthermore, in the section entitled, “‘Off-Label’ and Investigational Use of Market Drugs, Biologics and Medical Devices,” located at http://www. fda.gov/oc/oha/IRB/toc6.html#Off-Label, it is stated: Good medical practice in the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.