FDA ISSUES DRAFT GUIDANCE ON BIORESEARCH MONITORING PMA APPLICATIONS
The FDA has published draft guidance for the review and inspection of premarket approval (PMA) applications under its bioresearch monitoring (BIMO) program.
The guidance addresses the process for BIMO review of clinical and nonclinical information in PMA applications and related inspections, the agency said. Premarket notification, or 510(k), submissions are not addressed in the guidance, the agency noted.
The document, "Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program," 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).
Comments are due by September 18.