June 22, 2006

The FDA published draft guidance June 19 to assist devicemakers in preparing for FDA's review of their premarket approval (PMA) applications and for coordinating inspections for PMA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 covers one of the performance goals outlined in the 2002 Medical Device User Fee and Modernization Act (MDUFMA), which allows the FDA to collect user fees to help cover the cost of reviewing the manufacturing section of PMA applications and inspecting manufacturing facilities, the guidance notes.

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 application;

The administrative process for reviewing Quality System (QS) regulation information contained in a PMA application and the time frames involved in each step; and How the inspection of a manufacturing facility fits into the approval process.

The guidance does not address premarket notification, or 510(k) submissions, the FDA noted.

The guidance discusses three types of PMA applications:Traditional: An applicant submits complete scientific and technical manufacturing information along with "statistically valid and reliable data from clinical studies" at the same time in a single application.

Modular: An applicant submits a compilation of sections, or modules, separately that together become a complete application. Each module is a set of elements, tests or information on a particular aspect of the PMA. Expedited: The FDA will prioritize some applications that offer a clinically meaningful benefit as compared to existing alternatives.

The guidance also discusses three types of PMA supplements: panel-track, 180-day and real-time. ()a href="http://www.fdanews.com/ddl/33_25/" target=_blank>