Design Control Guidance - Food and Drug Administration

SECTION E. DESIGN REVIEWI. REQUIREMENTS§ 820.30(e) Design review.• Each manufacturer shall establish and maintain procedures to ensure that formaldocumented reviews of the design results are planned and conducted atappropriate stages of the device’s design development.• The procedures shall ensure that participants at each design review includerepresentatives of all functions concerned with the design stage being reviewed andan individual(s) who does not have direct responsibility for the design stage beingreviewed, as well as any specialists needed.• The results of a design review, including identification of the design, the date, andthe individual(s) performing the review, shall be documented in the design historyfile (the DHF).Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.6 Design review.II. DEFINITIONS§ 820.3(h) Design review means a documented, comprehensive, systematic examination ofa design to evaluate the adequacy of the design requirements, to evaluate the capability ofthe design to meet these requirements, and to identify problems.III. DISCUSSION AND POINTS TO CONSIDERIn general, formal design reviews are intended to:• provide a systematic assessment of design results, including the device design andthe associated designs for production and support processes;• provide feedback to designers on existing or emerging problems;• assess project progress; and/or• provide confirmation that the project is ready to move on to the next stage ofdevelopment.Many types of reviews occur during the course of developing a product. Reviews mayhave both an internal and external focus. The internal focus is on the feasibility of thedesign and the produceability of the design with respect to manufacturing and supportSection E. Design Review 3/11/97 Page 23