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# CDRH Reorganizing to Team Approach
- URL: https://www.fdaweb.com/cdrh-reorganizing-to-team-approach/
- Published: 2019-05-01T12:00:00.000Z
- Updated: 2026-09-15T01:23:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143997

CDRH says it is reorganizing “to create an agile infrastructure that can adapt to future organizational, regulatory, and scientific needs.” An online [post](https://www.fda.gov/about-fda/about-center-devices-and-radiological-health/reorganization-center-devices-and-radiological-health?utm%5Fcampaign=Announcing%20Implementation%20of%20CDRH%27s%20New%20Office%20of%20Product%20Evaluation%20and%20Quality&utm%5Fmedium=email&utm%5Fsource=Eloqua) says implementation of the reorganization is taking a phased approach that started 3/18 and will be completed by 9/30.

The post says that once fully implemented, the reorganization will generate efficiencies that will allow a fuller realization of the FDA and CDRH public health vision. The reorganization through a new Office of Product Evaluation and Quality (OPEQ) will integrate CDRH’s premarket and postmarket program functions along product lines, allowing Center experts to leverage their knowledge to optimize decision-making across the product lifecycle, it says. “Rather than assessing a device only at one point in time,” CDRH says, “for instance, to evaluate whether a device meets the standard for approval, or to evaluate postmarket data involving a device safety signal, reviewers, compliance officers, and other experts would work together in teams responsible for device oversight throughout the product’s development and commercialization,” the post says.

In an *FDA Voice* online [post](https://www.fda.gov/news-events/fda-voices-perspectives-fda-experts/implementing-team-based-approach-medical-device-and-radiological-product-evaluation-and-quality?ref=fdaweb.com), Center director **Jeffrey Shuren** and OPEQ director **William Maisel** says CDRH has been testing an OPEQ pilot for a year, which has produced significant improvements in its capabilities to streamline processes and more quickly address safety and other issues. The blog post gives several examples of issues that have come to OPEQ and how they have been resolved through the team approach.

CDRH says the reorganization does not change the Center mission or any MDUFA 4 timelines.