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CONTACT LENS CHEMICAL STERILANT LABELING REQUIREMENTS

This article was originally published in The Gray Sheet

Executive Summary

CONTACT LENS CHEMICAL STERILANT LABELING REQUIREMENTS will be reviewed as part of an effort to update FDA's contact lens disinfection product guidance, according to David Whipple, associate director for contact lenses in the Center for Devices and Radiological Health's ophthalmic devices division. Whipple announced the review at a Feb. 26 meeting of FDA's ophthalmic devices panel in Washington, D.C. Noting that "currently, most contact lens disinfection systems contain very broad, nonspecific ratings claims," Whipple said that the contact lens branch will be considering "labeling guidance that more precisely reflects the efficacy of the product." For example, instead of allowing a lens solution firm to state that its product "kills microorganisms," FDA may require the labeling to indicate whether the disinfectant also is fungicidal and viricidal, Whipple reported. Other possible modifications to the 1985 guidance include changing the "efficacy standards" outlined in the guidance and "the data requirements for establishing disinfection claims." He added that the revised document should "improve" the recommendations in this area by adding information on topics such as "how kill rates will be used to establish soak times and safety margins." FDA also may alter its recommendations regarding efficacy test methods, as well as the panel of microorganisms that should be used during testing, Whipple stated. FDA also is considering requiring the submission of "data from independent laboratory testing of the disinfection system," he added. Finally, Whipple said that the branch will be considering whether a separate set of standards should be developed for trial lenses used in doctors' offices. "The possibility, no matter how small, of patient-to-patient transfer of microbes through the use of trial lenses does exist," Whipple noted. He said that FDA reviewers should take into account whether "any chemical disinfection system [should] be labeled for use with trial lenses -- if it does not, for example, have viricidal efficacy in its soak step." Whipple also described contact lens branch involvement in International Standards Organization (ISO) efforts to develop "harmonized standards for contact lens products throughout the world." Particularly, he said, "chemical disinfection is one of the more complex and controversial standards being developed. Changes to standards in this area could have a significant impact on currently marketed disinfection products, as well as those under research and development." Whipple added that the branch, in an effort to preserve resources, has "combined some of our guidance review work with our ISO work." Among other ophthalmic policy issues raised at the Feb. 26 meeting was FDA's position on investigator-sponsored investigational device exemptions. Michael Blackwell, who heads the IDE section of the CDRH office of device evaluation's program operations staff, said that some recent problems warranted a public reiteration of FDA's policy in this area. Blackwell noted that while most of CDRH's IDE submissions come from manufacturers, investigators also may submit them. He explained that the problems are arising in cases where a manufacturer of a device already has received FDA approval of a protocol and then provides it to "interested investigators who...in turn submit sponsor/investigator IDEs." Blackwell stated that "our position has always been, and we are here to reemphasize, that if a sponsor/investigator IDE is submitted, and it contains a protocol which is identical to a protocol...already approved as the manufacturer's IDE, we would probably not act favorably upon that application." The agency, he said, could consider such an application to be an attempt to inappropriately extend a study protocol that already has been approved.
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