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<!– –> <!– Page Last Updated: 10/19/2015 –> Page Last Updated: 10/19/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

By: Robert M. Califf, M.D. and Jill Hartzler Warner, J.D. Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority. Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products…

The Food and Drug Administration (FDA) announced a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The topic discussed was challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and held a workshop focusing on design, development and performance evaluation of PCLC systems intended…

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<!– –> <!– Page Last Updated: 10/15/2015 –> Page Last Updated: 10/15/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.