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CDRH Announces Reorganization, Formation of Division of Standards and Conformity Assessment


The Center for Devices and Radiological Health (CDRH) has announced a reorganization: the Office of Strategic Partnership and Technology Innovation (OST) has been promoted to a CDRH Super Office, creating a new division dedicated to standards.

Through this reorganization, the Standards and Conformity Assessment Programs (S-CAP) has been promoted to division level and is now the Division of Standards and Conformity Assessment (DSCA). There are two programs within the DSCA: Standards Management Program (SMP) and Conformity Assessment Program (CAP). DSCA’s management team will be DSCA director Terry Woods, CAP assistant director Eric Franca, and SMP assistant director Jianchao Zeng.

“The Super Office designation allows the Center, specifically OST, to be well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers,” reads the FDA announcement.

Learn more in the FDA news release.

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