[Title 21 CFR C]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 820 - QUALITY SYSTEM REGULATION]
[Subpart C - Design Controls]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseCSubpart CFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATION
                       Subpart C--Design Controls



Sec. 820.30  Design controls.

    (a) General. (1) Each manufacturer of any class III or class II 
device, and the class I devices listed in paragraph (a)(2) of this 
section, shall establish and maintain procedures to control the design 
of the device in order to ensure that specified design requirements are 
met.
    (2) The following class I devices are subject to design controls:
    (i) Devices automated with computer software; and
    (ii) The devices listed in the following chart.

------------------------------------------------------------------------
              Section                              Device
------------------------------------------------------------------------
868.6810..........................  Catheter, Tracheobronchial Suction.
878.4460..........................  Glove, Surgeon's.
880.6760..........................  Restraint, Protective.
892.5650..........................  System, Applicator, Radionuclide,
                                     Manual.
892.5740..........................  Source, Radionuclide Teletherapy.
------------------------------------------------------------------------

    (b) Design and development planning. Each manufacturer shall 
establish and maintain plans that describe or reference the design and 
development activities and define responsibility for implementation. The 
plans shall identify and describe the interfaces with

[[Page 149]]

different groups or activities that provide, or result in, input to the 
design and development process. The plans shall be reviewed, updated, 
and approved as design and development evolves.
    (c) Design input. Each manufacturer shall establish and maintain 
procedures to ensure that the design requirements relating to a device 
are appropriate and address the intended use of the device, including 
the needs of the user and patient. The procedures shall include a 
mechanism for addressing incomplete, ambiguous, or conflicting 
requirements. The design input requirements shall be documented and 
shall be reviewed and approved by a designated individual(s). The 
approval, including the date and signature of the individual(s) 
approving the requirements, shall be documented.
    (d) Design output. Each manufacturer shall establish and maintain 
procedures for defining and documenting design output in terms that 
allow an adequate evaluation of conformance to design input 
requirements. Design output procedures shall contain or make reference 
to acceptance criteria and shall ensure that those design outputs that 
are essential for the proper functioning of the device are identified. 
Design output shall be documented, reviewed, and approved before 
release. The approval, including the date and signature of the 
individual(s) approving the output, shall be documented.
    (e) Design review. Each manufacturer shall establish and maintain 
procedures to ensure that formal documented reviews of the design 
results are planned and conducted at appropriate stages of the device's 
design development. The procedures shall ensure that participants at 
each design review include representatives of all functions concerned 
with the design stage being reviewed and an individual(s) who does not 
have direct responsibility for the design stage being reviewed, as well 
as any specialists needed. The results of a design review, including 
identification of the design, the date, and the individual(s) performing 
the review, shall be documented in the design history file (the DHF).
    (f) Design verification. Each manufacturer shall establish and 
maintain procedures for verifying the device design. Design verification 
shall confirm that the design output meets the design input 
requirements. The results of the design verification, including 
identification of the design, method(s), the date, and the individual(s) 
performing the verification, shall be documented in the DHF.
    (g) Design validation. Each manufacturer shall establish and 
maintain procedures for validating the device design. Design validation 
shall be performed under defined operating conditions on initial 
production units, lots, or batches, or their equivalents. Design 
validation shall ensure that devices conform to defined user needs and 
intended uses and shall include testing of production units under actual 
or simulated use conditions. Design validation shall include software 
validation and risk analysis, where appropriate. The results of the 
design validation, including identification of the design, method(s), 
the date, and the individual(s) performing the validation, shall be 
documented in the DHF.
    (h) Design transfer. Each manufacturer shall establish and maintain 
procedures to ensure that the device design is correctly translated into 
production specifications.
    (i) Design changes. Each manufacturer shall establish and maintain 
procedures for the identification, documentation, validation or where 
appropriate verification, review, and approval of design changes before 
their implementation.
    (j) Design history file. Each manufacturer shall establish and 
maintain a DHF for each type of device. The DHF shall contain or 
reference the records necessary to demonstrate that the design was 
developed in accordance with the approved design plan and the 
requirements of this part.