FDAnews Device Daily Bulletin

DRAFT GUIDANCE ISSUED ON BIMO PMA APPLICATIONS, INSPECTIONS

June 29, 2006
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The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BIMO) program.

The BIMO program includes comprehensive, on-site inspections and data audits to monitor all aspects of the conduct and reporting of FDA-regulated research, the agency says. The program is implemented domestically and internationally and addresses inspections of nonclinical testing labs, clinical investigators, contact research organizations sponsors, monitors and institutional review boards.

The BIMO program is unique in that its compliance activities and regulations are shared by all five FDA centers, the agency notes.

The guidance can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0228-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0228-gdl0001.pdf). ()a href="http://www.fdanews.com/ddl/33_26/" target=_blank>