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U.S. Department of Health and Human Services

About FDA

Compliance's Import Safety Initiative

Description: The overall objective of this project is to establish internal criteria and procedures for identifying devices that can be field examined and sampled:

  • Develop an electronic mechanism for identifying devices for field examination and for identification of devices to be sampled and analyzed at the Office of Regulatory Affairs (ORA) Winchester Engineering and Analytical Center (WEAC);
  • Improve field examination and sampling consistency by providing written internal criteria to all field investigators and by updating FDA's Predictive Risk-based Evaluation for Dynamic Import Compliance Testing (PREDICT), as appropriate; and
  • Improve communications with Division of Import Operations and Policy (DIOP) by conducting regular meetings to facilitate future decision-making and criteria and procedures development.

Another objective of this project is to improve imported products by improving our foreign inspection program:

  • Summarize the pilot Multipurpose Audit Program (pMAP) with Health Canada which is a sub-set of the Accredited Persons 3rd party inspection program to inspect manufacturers for compliance with International Organization for Standardization (ISO) 13485 and the US Quality Systems regulations; and
  • Complete/publish a pMAP report and progress to the next stage of globalization by developing a true Single Audit Program with Health Canada based on the experiences of the pilot.

Accomplishment: The successful conclusion of the pilot Multipurpose Audit Program with Health Canada resulted in a joint decision that FDA and Health Canada would develop and implement a true Single Audit program which will use regulatory third party audits to satisfy both regulators with one single audit and one singe audit report for both domestic and foreign manufacturers under this program.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Create a preliminary evaluation of the entry review process

11/15/2009

Completed 10/25/2009

B. Develop internal criteria and procedures, in collaboration with ORA's DIOP, for devices to be field examined or collected

12/1/2009

Completed 12/1/2009

C. Develop a project plan for conducting field exams and sample collections

1/15/2010

Completed 1/1/2010

D. Complete internal criteria and procedures and test in the field

4/15/2010

Completed 4/15/2010

E. Implement finalized internal criteria and procedures

6/1/2010

Completed 5/27/2010

F. Complete the FDA program evaluations of the Pilot Multipurpose Audit Program Report (pMAP) and submit to Health Canada

7/1/2010

Completed 1/31/2010

G. Schedule a follow-up meeting to refine agreements and work between FDA and Health Canada on finalizing the pilot program and planning the development of a Single Audit Program

10/1/2010

Completed 7/31/2010

H. Establish a collaborative mechanism with FDA's Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), and Center for Biologics Evaluation and Research (CBER) to improve internal operations of the CDRH Import Export Staff.

11/30/2010

Completed 11/16/2010

I. Develop an internal process by which a device shortage assessment is conducted prior to placing a product/firm on an import alert.

12/31/2010

Completed 11/29/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.