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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

preclinical

FDA changes that are now in effect.

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and […]

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility […]

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preclinical

FDA CDRH Experiential Learning Program is open for comments

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 23, 2017 that the submission period for Experiential Learning Program (ELP) in open. ELP is a training component intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other […]

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