Guidance on Quality Information

Originally Published MDDI April 2003

NEWSTRENDS

James Dickinson

FDA has released a guidance to help medical device manufacturers prepare and maintain the quality system information required in premarket submissions. Entitled Quality System Information for Certain Premarket Application Reviews, the document replaces Guidance for Preparation of PMA Manufacturing Information, issued in August 1999.

The updated guidance is intended for use with PMA, PMA-supplement, PDP, HDE, and modular-review submissions. It recommends that sponsors submit specified information on design controls. The areas covered include design and development planning, design input, design output, review, verification, validation, transfer, and changes. A design history file is also required. 

The guidance also gives a list of required manufacturing information for each submission. The items named include a quality manual, a production flow diagram, purchasing control procedures, a process validation master plan, validation procedures, final acceptance activities procedures, and corrective and preventive action procedures.

The guidance may be viewed by visiting www.fda.gov/cdrh/comp/guidance/1140.pdf. 


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