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SHARPS CONTAINERS WILL REQUIRE PMAs IN CERTAIN CASES

This article was originally published in The Gray Sheet

Executive Summary

SHARPS CONTAINERS WILL REQUIRE PMAs IN CERTAIN CASES, FDA says in a draft guidance document on 510(k) submissions for the devices. According to the recently completed draft, sharps containers that "remove sharps off the needle hub, typically by means of an electrical charge or heat, present a new type of safety and effectiveness issue" and therefore cannot be cleared for marketing via the 510(k) substantial equivalence process. The devices, FDA says, are "Class III products requiring premarket approval or reclassification to Class I or II before they may be marketed." The draft is being issued in conjunction with an FDA announcement of the regulatory status of sharps containers. During the week of Oct. 11, the agency plans to issue a letter to container manufacturers that will explain that their devices require premarket clearance; FDA had been expected to issue the letter in mid-1992 ("The Gray Sheet" May 3, p. 6). FDA, which considers the majority of sharps containers to be Class II accessories to sharps devices, did not begin to actively regulate the products until 1990. As a result, many products currently being sold have not received agency marketing clearance. Since January, FDA has received 20-30 510(k)s for the devices. However, 17 of the submissions were found to be deficient due to insufficient data, and 4-5 were found to be not substantially equivalent. FDA's formal announcement of its sharps container policy "may provide a grace period for submission of 510(k)s," the guidance states. FDA adds that although all 510(k)s must include a comparison to a legally marketed device, "there will be a period of time during this transition in regulatory control where some currently marketed containers are still pending FDA clearance, making confirmation of legality of a predicate device problematic in the short term." Nevertheless, manufacturers "should provide a comparison of their device to ones available on the market and to available standards," FDA says. In reviewing an application, FDA will evaluate "whether a sharps container has features that are consistent with current good infection control practices, for instance, as expressed in" the Occupational Health and Safety Administration's bloodborne pathogens regulations, the guidance says. The agency notes that although it is working with OSHA to mitigate the risk of bloodborne infections, FDA clearance of a sharps container "does not preclude OSHA from finding the device and/or its use to be violative under OSHA regulations." If OSHA objects to a design cleared by FDA, and the product is subsequently reworked to make it acceptable to OSHA, the manufacturer must submit a new 510(k) for the changes, FDA points out. The draft guidance includes a checklist of components for a 510(k) submission. Guidelines for the cover letter, labeling, general description, design features, and design feature specifications are provided. For example, FDA says that design validation test methods must include pass-fail criteria for each of the design feature specifications "and the safety and effectiveness basis for the criteria, (e.g. a standard)." The document lists several standards for sharps containers that can be used to determine appropriate test methods. In the section concerning design features of containers for contaminated sharps, FDA says that manufacturers should certify certain characteristics of the devices, including whether they are puncture resistant; capable of maintaining a stable, upright position; and are leakproof on the sides and bottom. The guidance also points out that the device should have "no feature to bend, break or shear the needle (includes blunting and melting of needle)."
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