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This article was originally published in The Gray Sheet

Executive Summary

OLYMPUS PREPARING 510(k)S FOR NINE WITHDRAWN LAPAROSCOPIC INSTRUMENTS; shipments of the instruments were suspended early in January after the firm received a Dec. 31 letter from FDA stating that "premarket notification submissions were not provided as required...when significant changes were made" to the devices. Olympus expects to submit 510(k)s for the modifications in the next several weeks. The nine devices cited in the warning letter are: 10 mm "angled dissecting unipolar forceps (Maryland Dissector)"; 5 mm "coagulating dissecting/grasping forceps"; 5 mm insulated ratchet handle grasping forceps; "claw forceps" with a 10 mm shaft and 5 mm jaw; 5 mm "long hook electrode with channel"; 5 mm "spatula electrode with channel"; 5 mm unipolar hook scissors; 5 mm micro curved scissors; and 4 mm micro scissors. Olympus designed the devices and received initial 510(k) clearance for the products in 1979. The devices were manufactured by an OEM supplier and distributed by Olympus. The warning letter is based on the findings of an FDA inspection of Olympus' Lake Success, New York manufacturing facility on "various days" between March 31 and June 4, 1992. Olympus says that at the time of the inspection, it maintained that 510(k)s should not be required for the design modifications; however, the firm decided to make the submissions after receiving the warning letter. 3M Health Care recently received some good news from FDA regarding an Aug. 28 warning letter related to arthroscopic sheathed knives and Maxi-Driver II oscillating saws. In a Dec. 16 letter to the company, the agency acknowledges that the warning letter and earlier FDA-483 inspectional observation report to 3M "should not have been issued." In September, 3M had challenged the FDA decision to issue the warning letter and 483, arguing that problems cited by FDA's Los Angeles district office had been corrected before the June inspection of 3M's Orthopedic Products division in Irvine, California. FDA notes in the December correspondence that 3M's "principal contention appears to be that both the FDA-483 and warning letter should not have been issued since the deficiencies cited represented problems associated with the products more than one year before our June 1992 inspection, and had been fully corrected as acknowledged by our investigator." FDA agrees with 3M's argument that "under the usual circumstances warning letters are issued for current violations that had not been corrected, and not for past violations which had been corrected." The agency adds, however, that "the current written policy for warning letters does not specifically preclude such issuance retrospectively." FDA explains that, because of earlier 3M product recalls, the agency "considered the deviations reported to be serious and, as such, of 'regulatory significance' at the time the recalls were initiated." The agency says that the warning letter initially was sent because "the District determined that a formal advisory to top management at 3M concerning the violations leading to the two recalls at the Irvine facility was warranted." The agency continues: "An additional concern of ours has been [the] 16 recalls conducted by 3M's Life Sciences sector within the past five years with respect to" devices and drugs. "Although we recognize that this figure represents several manufacturing divisions...and [the recalls] were conducted for a variety of reasons, we believe that, overall, this constitutes a significant number occurring within this period." In response to 3M's request that FDA withdraw the warning letter and FDA-483 and revise an establishment inspection report, the agency explains that regulations prohibit the alteration or removal of such documents. FDA adds, however, that the Dec. 16 letter will be added to 3M's establishment inspection file and be placed on public display.

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