TY - JOUR
T1 - Using the Monocyte Activation Test as a Stand-Alone Release Test for Medical Devices
AU - Brown, Jeffrey
AU - Clippinger, Amy J.
AU - Briglia, Claire Fritz
AU - Casey, Warren
AU - Coleman, Kelly
AU - Fritsch, Anja
AU - Hartung, Thomas
AU - Maouyo, Djik
AU - Muller, Thierry
AU - Reich, Johannes
AU - Robert, Laure
AU - Roeder, Ruth
AU - Sanchez, Guillermo
AU - Sawyer, Anita Y.
AU - Solati, Shabnam
AU - Tirumalai, Radhakrishna
AU - Zwisler, Walter
AU - Allen, David
N1 - Funding Information:
This workshop was funded by the PETA International Science Consortium Ltd. and NICEATM with federal funds from the National Institute of Environmental Health Sciences, the National Institutes of Health under Contract No. HHSN273201500010C to ILS in support of NICEATM. We thank the U.S. Food and Drug Administration for their critical feedback on this workshop report.
Publisher Copyright:
© 2021 ALTEX Edition. All rights reserved.
PY - 2021
Y1 - 2021
N2 - Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and follow-up activities are discussed.
AB - Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and follow-up activities are discussed.
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U2 - 10.14573/altex.2012021
DO - 10.14573/altex.2012021
M3 - Article
C2 - 33452530
AN - SCOPUS:85100360874
SN - 1868-596X
VL - 38
SP - 151
EP - 156
JO - ALTEX
JF - ALTEX
IS - 1
ER -