Originally Published IVD Technology June 2003
INDUSTRY NEWS
CDRH calls for comments on multiplex testing guidanceFDA is requesting industry feedback on its draft guidance on multiplex tests, or tests that assay multiple analytes simultaneously, for heritable DNA markers, mutations, and expression patterns. The guidance was released by the Center for Devices and Radiological Health (CDRH) on April 21, and comments from IVD manufacturers and other stakeholders will be accepted until July 21. The agency will review all suggestions, revise the guidance, and release a second draft guidance for review before releasing a final version.
The document offers recommendations for preparing and reviewing premarket approval (PMA) submissions for multiplex and array tests. It proposes a basic framework for the types of data that should be included in submissions for such tests. Although the guidance is intended to be used primarily for PMA submissions, many of the scientific issues it raises will be relevant to premarket notification 510(k) submissions as well.
The agency proposes a partnership with industry to further develop the guidance and facilitate the transfer of multiplex and microarray tests into the marketplace. Interested parties have been invited to comment on whether the content of the document is clear, comprehensive, and achieves its purpose of providing adequate assistance for developing submissions that support the marketing of safe and effective products.
An open dialogue between FDA and industry is particularly important in this case because this is the first draft of multiplex-testing review criteria offered to the IVD industry. According to the guidance, the agency views multiplex and microarray testing as a "new and important technology," and is eager to partner with industry in pointing the way to the least burdensome path for sending this new technology to market in a timely manner.
The draft guidance can be accessed on-line at http://www.fda.gov/cdrh/oivd/guidance/1210.pdf. Comments on the guidance can be submitted electronically to the dockets management branch of FDA at http://www.fda.gov/dockets/ecomments.
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