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This article was originally published in The Gray Sheet

Executive Summary

GERMICIDES FOR CRITICAL AND SEMICRITICAL DEVICES WILL BE REGULATED BY FDA under a June 4 memorandum of understanding between FDA and the Environmental Protection Agency. The agreement states that "FDA will be primarily responsible for the premarket review of safety and efficacy requirements for liquid chemical germicides that are sterilants." For purposes of the agreement, sterilants are defined as "those chemical germicides used to reprocess reusable critical and semicritical devices." Critical devices are defined in the memorandum as those which are "introduced directly into the human body" and include laparoscopes, surgical instruments, heart-lung oxygenators and transfer forceps. Semicritical devices, such as endotracheal tubes, cytoscopes, and vaginal specula, are defined as "those which contact intact mucous membranes" but do not "penetrate the blood barrier or otherwise enter normally sterile areas of the body." Under the MOU, EPA will be responsible for the regulation of the other category of germicides -- general purpose disinfectants, which are defined as "those chemical germicides used to reprocess noncritical devices and medical equipment surfaces." Examples of noncritical devices cited in the document include wheelchairs, medical beds and lamps, dental units and stethoscopes. The objective of the MOU is to "minimize redundant regulation" by both FDA and EPA of liquid chemical germicides used on devices "while assuring and efficacy requirements" are met, according to the document. Germicide manufacturers have complained that the dual regulation of their products is overly burdensome. The Food, Drug and Cosmetic Act gives FDA the authority to regulate germicides as devices. Because germicides have not been classified by the agency, FDA regulates them as accessories to the devices on which they are used. Currently, all manufacturers of germicides used on medical devices, excluding pre-amendment germicides, are required to submit a premarket notification or premarket approval application to FDA to market their products. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), germicides are regulated as pesticides and must be registered with EPA. Under the respective statutes, both FDA and EPA have authority to take enforcement action against noncompliant germicide manufacturers. FDA's regulatory activities in the germicide area are relatively recent. In 1990, FDA and EPA entered into an interagency pact to test the efficacy of chemical sterilants considered "crucial to infection control." The agency began to enforce its regulatory policy in 1991, taking action against at least two germicide manufacturers, Metrex and Sporicidin International. In January 1992, FDA issued a guidance document outlining requirements for germicide 510(k)s. Some manufacturers have responded unfavorably to FDA's interest in regulating germicides. In a March letter to the agency, the Chemical Specialties Manufacturers Association asserted that further regulatory action "should be suspended" until FDA formally classifies germicides as separate devices and reviews comments on the January 510(k) guidance ("The Gray Sheet" March 22, p. 15). Under the terms of the MOU, sterilants that receive FDA marketing clearance through the 510(k) or PMA approval process will be considered as having satisfied "certain" requirements for registration under FIFRA. When a manufacturer submits an order issued by FDA granting marketing clearance or approval for a sterilant, "EPA will consider the efficacy data requirements for registration to be satisfied." However, EPA may still need to consider the product's chemical, ecological and toxicological effects before registering the germicide. The MOU says that EPA intends to completely exempt liquid chemical sterilants from regulation under FIFRA at some point in the future. Concurrently, FDA will consider that all general purpose disinfectants that are registered with EPA "satisfy the criteria necessary to determine substantial equivalence," according to the MOU. The manufacturer of the disinfectant will be required to submit to FDA a copy of the EPA correspondence granting registration, whereupon "FDA will issue an order finding the product substantially equivalent to a predicate device." The MOU notes that FDA intends to initiate its germicide classification effort and will recommend to "its classification advisory panel that...germicides that are not critical or semicritical devices be exempted from the FD&C Act." FDA announced plans to classify germicides in July 1992 ("The Gray Sheet" July 6, 1992, p. 18). The MOU points out that EPA will require, as part of the registration process, that germicides that are not sterilants state on their product labels: "This product is not to be used on any surface or instrument that (1) is introduced directly into the human body...or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body." Also outlined in the MOU are the respective compliance responsibilities of the agencies. FDA will be responsible for all "sampling and all efficacy testing of liquid chemical sterilants," as well as "instituting any enforcement and/or regulatory action." EPA will responsible for the same duties for all general purpose chemical germicides. The two agencies will be expected to share all pertinent information to effectively coordinate regulation and enforcement. The MOU notes that it has "no effect on any pending investigations or enforcement or regulatory actions undertaken by EPA...or FDA." In addition, the MOU establishes an EPA/FDA interagency committee to "ensure the continued coordinated regulatory compliance and enforcement activities for liquid chemical germicides." The directors of the registration division and the compliance division, both in the EPA's office of prevention, pesticides and toxic substances, and the director of the FDA device center's office of compliance and surveillance will act as chairpersons of the committee, which will meet "a minimum of twice each fiscal year," according to the memorandum.

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