The FDA published draft guidance June 19 to assist devicemakers in preparing for FDA's review of their premarket approval (PMA) applications and for coordinating inspections for PMA supplements.
The guidance discusses:
The steps that will be taken by the Office of Compliance (OC) or the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) when they review the manufacturing section of a PMA; The administrative process for reviewing Quality System (QS) regulation information contained in a PMA and the time frames involved in each step; and How the inspection of a manufacturing facility fits into the approval process.
The "Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Application Manufacturing
Information and Operations," can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0063-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0063-gdl0001.pdf).