10 novembre, 2006 10:32

Medical Device Postmarket Transformation Initiative

CDRH 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 January, 2006 the Center convened a senior leadership team (the Postmarket Transformation Leadership Team-PTLT) which included external medical device experts.

The team’s charge was to:

"evaluate the recommendations in the CDRH document, "Ensuring the Safety of Marketed Medical Devices – Executive Synopsis and Recommendations," (January ’06), collect additional data as necessary, supplement the recommendations, if needed, and propose a prioritized implementation plan for a transformed postmarket process".

The report recommendations elaborated the four areas designated for improvement in the previous postmarket reports. They are:

* Create a Culture of Collaboration

The Center should transform its operations by adding a permanent matrix of cross-cutting product-related groups over the current functionally-based organizational structure to foster information sharing, collaboration and, ultimately, more effective public health promotion and protection. The cross-cutting matrix is designed to ensure that collaboration occurs not just in crisis situations, but also as a part of routine, day-to-day operations.

* Develop World Class Data Systems

Data input, mining, analysis, and tracking systems should be strengthened, improved, or created as needed for postmarket issues. Improvements to the Center’s critical medical device data and information systems including MAUDE and the MDR system are highlighted as well as pursuing additional enhancements to enhance the Center’s analysis and tracking capabilities.

* Enhance Risk/Benefit Communication Efforts

CDRH should be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products. To that end, an analysis of the communication needs of CDRH stakeholders should be performed, and a process for the development and dissemination of risk-benefit information should be done in collaboration with clinical practitioners and professional communities.

* Collaborate on Enforcement Strategies and Outcomes

Both the quantity and the quality of Center /ORA interactions should be transformed through increased collaboration among CDRH, the Office of Regulatory Affairs, and the Office of Chief Counsel. Postmarket data and information should be considered when prioritizing inspections and the inspection preparation process should include a review of recent postmarket data. CDRH should develop ways to leverage the audit results obtained by accredited third-party auditing bodies. Enforcement data systems should be updated, and employees trained to use them. All available enforcement tools should be used, including civil money penalties.

Immediate priority actions were identified by the PTLT. They are to:

* Create a matrix of collaborative product groups to complement the largely functional organization of the Center

* Develop metrics and methods for tracking the handling of postmarket issues

* Pursue the development of unique identifiers (UDI) for medical devices

* Propose mandatory electronic MDR reporting

* Revise and update the MAUDE system, and expand the premarket data-warehousing project to include postmarket needs

* Increase the quality and quantity of Center/ORA/OCC interactions

* Develop and implement a risk-communication strategy

* Design a pilot project to test the usefulness of quantitative decision-making methods for medical device regulation across the total product life cycle

• Enhance utility of MedSun programs

PS All reports are in TEXT or PDF forms (TONY)

"Report of the Postmarket Transformation Leadership Team: Strengthening FDA’s Postmarket Program for Medical Devices" which provides an action plan for changes to the medical devices postmarket program. (November 2006)

Questions & Answers - External Audience (November 2006)

Press Release (November 2006)

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. (January 2006)

A separate Synopsis and Recommendations document provides a list of initial action steps the Center will take to strengthen postmarket effectiveness. (January 2006)

A presentation titled "Ensuring the Safety of Marketed Medical Devices" by Dr. Daniel Schultz, Director, Center for Devices and Radiological Health (January 4, 2006)