The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

3 Device Divisions To Fall Under Program Alignment

May 6, 2016
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CDRH soon will have three medical device divisions that are responsible for monitoring and managing the entire establishment inventory both domestically and globally, under its new program alignment.

That represents a significant change from the existing structure, said Sean Boyd, acting director of CDRH’s Office of Compliance, during FDAnews’ Medical Device Quality Congress in Rockville, Md. in March.

Currently, the FDA’s field operation is organized geographically with five regional offices — Pacific, Central, Northeast, Southwest and Southeast — and 20 district offices.

In the future, the U.S. will be one region instead of five. The three device divisions will be located in areas of the country where members of medical device industry are clustered, Boyd said.

“We are not looking to move investigators from one location to the next,” he said. “There might be some instances where there is some more travel required where we don’t have a device investigator in a particular area right now.”

The FDA’s Office of Regulatory Affairs is moving forward with its program alignment, and the agency plans to implement the new regulatory organizational model next year. Officials are working to finalize details, such as the job description of investigators, compliance officers or managers within ORA, he said.

“This the most dramatic change that ORA has experienced maybe in its history, so it will take time to communicate and ensure that people understand what is trying to be accomplished,” he added.

The planned changes under program alignment come as new data shows the FDA has been conducting more quality systems inspections at foreign devicemakers.

What will CDRH expect of your quality management systems in the new environment? CDRH in Transition: Preparing for a New Enforcement System spells out how — and when — CDRH plans to update its programs in the coming years and how devicemakers should respond. Think of it as your to-do list for the next 18 months.

 

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