The CDRH Postmarket Transformation Leadership Team is expected to have recommendations back to CDRH within approximately four months.

CDRH Role in Medical Device Postmarket Transformation Initiative


Through the initiative, the Center for Devices and Radiological Health is taking steps to increase its ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products. In 2005, the Center conducted a comprehensive inventory of its postmarket safety programs, including recalls, MDR and MedSun. In each of these areas, we looked at our successes and our challenges in implementing an effective program.

CDRH reports that the postmarket safety program inventory considered
* how we identify postmarket problems;
* how we assess the information we obtain; and
* how we respond to that information through both stakeholder communication and enforcement action.

The Center's plan to strengthen its postmarket program focuses on
* developing a "culture of collaboration" for postmarket safety within the Center;
* developing world-class data sources and systems to quickly and accurately collect, analyze, and disseminate information about potential risks;
* enhancing risk communication efforts; and
* improving coordination with the FDA field staff.

A senior-level team, comprised of CDRH management and outside consultants experienced in medical device safety and product regulation, will help guide the Center in this effort.

To obtain a copy of CDRH's Medical Device Postmarket Safety Program or Synopsis and Recommendations, see: www.fda.gov/cdrh/postmarket/mdpi.html.

The link provides access to a prepared a report, "Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Postmarket Safety Program," which documents the postmarket inventory and discusses the CDRH postmarket program. The separate Synopsis and Recommendations document provides a list of initial action steps the Center will take to strengthen postmarket effectiveness. Also available on the web site is a presentation titled "Ensuring the Safety of Marketed Medical Devices."

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