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Imminent Combo Products Guidance to Reflect Rapidly Changing Technology

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Thursday. Patricia Love, deputy director of the Office of Combination Products, said her staff is “working feverishly” to finalize the document. “It’s time to start watching the Federal Register,” she told attendees at a Thursday session of the FDA Small Business Regulatory Education for Industry Conference in Washington, D.C.
Devices & Diagnostics Letter