Center for Devices and Radiological Health
DESIGN CONTROL GUIDANCE
MEDICAL DEVICE MANUFACTURERS
This Guidance relates to
FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001
March 11, 1997
To ensure that good quality assurance practices are used for the design of medical devices
and that they are consistent with quality system requirements worldwide, the Food and
Drug Administration revised the Current Good Manufacturing Practice (CGMP)
requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820.
An important component of the revision is the addition of design controls.
Because design controls must apply to a wide variety of devices, the regulation does not
prescribe the practices that must be used. Instead, it establishes a framework that
manufacturers must use when developing and implementing design controls. The
framework provides manufacturers with the flexibility needed to develop design controls
that both comply with the regulation and are most appropriate for their own design and
This guidance is intended to assist manufacturers in understanding the intent of the
regulation. Design controls are based upon quality assurance and engineering principles.
This guidance complements the regulation by describing its intent from a technical
perspective using practical terms and examples.
Draft guidance was made publicly available in March, 1996. We appreciate the many
comments, suggestions for improvement, and encouragement we received from industry,
interested parties, and the Global Harmonization Task Force (GHTF) Study Group 3.
The comments were systematically reviewed, and revisions made in response to those
comments and suggestions are incorporated in this version. As experience is gained with
the guidance, FDA will consider the need for additional revisions within the next six to
The Center publishes the results of its work in scientific journals and in its own technical
reports. Through these reports, CDRH also provides assist