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Total Product Life Cycle Model (TPLC)
"Apply TPLC across Center activities to
promote and protect the public health."
TPLC Goals:
Educate and partner with staff and stakeholders.
Use scorecards to align Center work with TPLC.
Use multiple pilots to accelerate implementation.
Realign Center incentives to support TPLC.
Harmonize CDRH and international regulation.
Successful Implementation of TPLC will mean:
Meeting all statutory responsibilities, and identifying product areas
of high public health need, encouraging innovation, and developing science-based
regulation.
Risk management throughout the Total Product Life Cycle using the least
burdensome means for industry.
Balance, flexibility and science in promoting and protecting the public
health. Considering alternate balances of premarket and postmarket regulation.
Access to state-of-the-art scientists in relevant product areas. Developing
a large network of partners. Educating staff and stakeholders on the paradigm.
Fast tracking for high priority products.
Decreasing medical errors using risk communication and human factors engineering.
Responsiveness to stakeholders and dispute resolution.
Improved application quality and more consistent consequences for incomplete
applications.
Developing and integrating performance measures for each organization
in the Center to implement the strategic plan.
More information on TPLC:
Updated June 10, 2005 |
