About FDA

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.