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FDA addresses ASRs

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 1, 2007

The FDA is using a question and answer format to offer guidance to manufacturers of commercial analyte specific reagents (ASRs), which the FDA notes are the "building blocks" of laboratory developed tests. The guidance does not apply to laboratory development of such tests.

In the guidance, the Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) and Center for Biologics Evaluation and Research (CBER) answer some common questions about marketing ASRs. The guidance explains an ASR otherwise exempt from pre-market notification requirements becomes an in vitro diagnostic device, potentially subject to pre-market notification requirements if the manufacturer:

• combines, or promotes the use of, the ASR with other ASRs, reagents, or similar products or laboratory instruments;
• makes "specific analytical or clinical performance claims" or provides instructions for use in or validation of a specific test.

The guidance answers questions about the definition of an ASR, the rules applicable to ASRs, and the classification of ASRs. The FDA notes that while most ASRs are exempt from pre-market notification as Class I exempt devices, Class II or III ASRs may require pre-market submissions. Manufacturers should use the guidance to help them determine if their device qualifies as an ASR and contact OVID or CBER if they are still unsure about the proper classification, according to the FDA.

The guidance also provides examples of entities that are considered ASRs (such as a single antibody) and those that are not ASRs (such as multiple ASRs combined together so they must be used in the same test). Finally, the guidance provides answers to questions about to whom manufacturers can sell ASRs and what manufacturers can and cannot do with regard to marketing ASRs.

You can review the Q&A on the FDA's Web site. The FDA notice announcing the guidance was published in the September 14, 2007 Federal Register.

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