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This article was originally published in The Gray Sheet

Executive Summary

FDA will propose the elimination of its particularized regulations for intraocular lens investigations in an upcoming proposed rule. Clinical trials for IOLs have been regulated separately from all other device investigations for years. While the original IDE regulation proposed by FDA in 1976 encompassed all medical devices, including IOLs, the comments on that proposal persuaded FDA to proceed immediately with a final rule applicable to IOLs alone. In the November 1977 final rule on IDE requirements for IOLs (21 CFR part 813), FDA stated that "when the general investigational device regulations are published in final form and become effective, the Commissioner will rescind those portions of these regulations applicable to investigational studies of intraocular lenses that are adequately covered by the general regulations." However, when the agency published its final general regs for IDEs in January 1980, it left the IOL regulation in place on the grounds that investigators, sponsors and FDA were already familiar with part 813. "FDA has reexamined the need to retain part 813 and has concluded that maintaining a regulatory distinction between the IOL studies and other medical device studies is no longer justified," the proposed rule states. The proposal notes that the IOL regulations require some information not entailed by the general reg, "such as a more detailed description of the ingredients, properties, and operation of the device." However, the agency feels that such differences are "insignificant" and that submissions will continue to contain essentially the same information. The investigational IOL regulations also contained provisions pertaining to the disqualification of clinical investigators. At the time, FDA expected later to finalize an agency-wide proposed rule on clinical investigator disqualification. That final rule was never published, although some of its provisions were included in the agency's investigational new drug regulations. As a result, FDA is now generalizing the IOL provisions regarding disqualification to cover all medical devices, via a separate proposed rule to be published in the same Federal Register issue (see related story, p. 3). The original statutory intent behind the separate rules for IOLs was to ensure that IOLs were "made reasonably available to qualified investigators," the proposed rule explains. "To these ends...sponsors of ongoing IOL investigations were permitted to distribute IOLs under an adjunct phase." FDA began phasing out adjunct studies in 1988, however, and at present, "all investigational IOLs are limited to controlled distribution in a manner that can be appropriately regulated under the IDE regulation." FDA says it has approved "over 250" premarket approval applications and PMA supplements for IOLs. "With the elimination of the adjunct phase of IOL studies, investigations of IOLs no longer have this distinguishing characteristic that may once have justified separate regulatory treatment."

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