Katrina’s Blog™

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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

47 New Medical Devices Approved under PMAs and HDEs in 2018

December 11, 2018
| Uncategorized

– Approvals Occurred Between 21DEC2017 and 18SEP2018

Each year the FDA publishes data on the devices receiving approval through the various submission pathways. References to much of this information are available in several locations including the Federal Register. In mid-November, the agency published a list of the new devices receiving PMA or HDE approval announced since the beginning of 2018. This list comprises 47 new devices, and the safety and effectiveness details for each device may be found by looking up the PMA number in the PMA Database or HDE Database. Patients, physicians, and sponsors all may find this information useful for their various needs.

Text Copyright © 2018 Katrina Rogers

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