FDA > CDRH > Strategic Plan > Public Health Impact (PHI)

Public Health Impact (PHI)

"Measure and communicate our impact on the public health"

PHI Goals

New initiatives will have explicit metrics

Use pilots and demonstrations to refine methodology

Use Performance Measures to align Center work with strategic plan

Develop industry report cards

Design results-based budgets
 

Successful Implementation of PHI will mean:

Stakeholder involvement in public health impact and tool development, and leveraging external expertise and data.

Developing MedSun and improving access to external databases to increase our knowledge base about products.

Using outside resources such as third parties to inspect for GMP compliance based on a random sampling of Class I, 510(k) exempt device manufacturers.

Developing public Industry Report Cards about industry overall (not individual companies.) Becoming the "Consumer Reports for Medical Devices and Radiological Health".

Building metrics into the budgeting and planning cycle, and developing reporting systems for products that dovetail current work.

More Information on PHI

Class I inspection PPT Text
MEDSUN

Updated February 11, 2004