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This article was originally published in The Gray Sheet

Executive Summary

IVD ON-SITE TESTING REQUIREMENTS SHOULD BE REDUCED to one site from the three currently proposed in FDA's draft guidance on 510(k) submissions for in vitro diagnostics subject to the Clinical Laboratory Improvement Amendments of 1988, Baxter says in recent comments to the agency. The company argues that the requirement to have end user field studies "for at least three sites is more than is currently practiced and more than required by regulation." The draft guidance, released Jan. 12, describes criteria for FDA clearance of IVD quality control instructions under CLIA ("The Gray Sheet" Jan. 18, p. 3). According to the document, to gain clearance of QC labeling, firms should conduct on-site testing to validate quality control instructions in "at least three laboratories." These field studies are intended to "demonstrate that QC instructions are valid when QC is performed by testing personnel with the minimum qualifications permitted" under CLIA regulations (emphasis FDA's). In its comments, Baxter opposes the agency's proposal that user field testing be performed by minimally qualified personnel. The company contends that "labs using staff with minimum qualifications may not be widely available" due to individual laboratory regulations and "state licensing requirements for education and training levels that exceed" those detailed in CLIA. The company further states: "A manufacturer should be able to serve as a 'user field site' if personnel having the same [minimum] qualifications as the labs certified to run tests are used during the internal studies." Meridian, one of several other IVD manufacturers to submit comments on the guidance, echoes Baxter's disapproval of field studies using minimally qualified personnel. The company asserts that "the request is unreasonable" for several reasons. Meridian points out that "manufacturers will not know the complexity level to be assigned at the time the studies are to be performed," and thus will be unable to determine the precise minimum qualifications required under the regulation. Meridian also asserts that while "the minimum qualification for both moderately and highly complex [IVD] categories is an academic high school diploma" or equivalent, "relatively few laboratories employ" personnel with this minimal educational level, and if current "hiring practices continue, there will be even fewer." Thus, Meridian maintains, "gathering of QC data will be unnecessarily difficult." Under CLIA regulations, testing personnel performing high complexity tests must have at least an associate degree after 1997. Until that time, personnel with high school diplomas may conduct high complexity tests if overseen by a "general supervisor." For moderate complexity IVDs, testing personnel can have either a high school diploma and "appropriate training" or an associate degree. Both Baxter and Meridian express concerns with the guidance document's reliance on "proposed" National Committee for Clinical Laboratory Standards guidelines. Baxter argues that the proposed documents are in a constant state of revision and therefore should not be used as standards against which IVD submissions are judged. The company states that the NCCLS documents should only be used as voluntary guidelines for the manufacturer, who should be provided "the flexibility to make appropriate adjustments." Meridian voices a more specific concern, pointing out the failure of the NCCLS documents to address all areas of diagnostic testing. The company cites the unavailability of NCCLS guidelines that address "qualitative methods," such as IVDs "which report the presence of an antigen or antibody," and suggests that FDA should provide either their own guidelines or "adequate references" for these qualitative methods. Meridian also questions FDA's proposal to subject all IVD premarket notifications to an in-depth CLIA-type QC labeling review, even if such a review has not been requested by the manufacturer. "The guideline does not specify the details or extent of this in-depth review. In these situations, under what authority does the FDA modify the extent or content of the QC review they are currently performing?" the company asks.

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