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Coming Combo Products Guidance to Reflect Rapid Technology Changes

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Sept. 20. The guidance takes into account new regulatory priorities, such as human factors, that affect combination product approvals. While human factors may not have been considered a decade ago, manufacturers now submitting combination product applications are expected to address those concerns, Angela Krueger, product jurisdiction officer in the Center for Devices and Radiological Health’s Office of Device Evaluation, said.
Washington Drug Letter