SECTION A. GENERAL

SECTION A. GENERAL

I. REQUIREMENTS

§ 820.30(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 chart below.

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

II. DEFINITIONS

§ 820.3 (n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

§ 820.3 (s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

§ 820.3 (v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Cross reference to ISO 9001:1994 and ISO/DIS 13485 Section 4.4.1 General.

III. DISCUSSION AND POINTS TO CONSIDER

The essential quality aspects and the regulatory requirements, such as safety, performance, and dependability of a product (whether hardware, software, services, or processed materials) are established during the design and development phase. Deficient design can be a major cause of quality problems.

The context within which product design is to be carried out should be set by the manufacturer's senior management. It is their responsibility to establish a design and development plan which sets the targets to be met. This plan defines the constraints within which the design is to be implemented.

The quality system requirements do not dictate the types of design process that a manufacturer must use. Manufacturers should use processes best suited to their needs. However, whatever the processes may be, it is important that the design controls are applied in an appropriate manner. This guidance document contains examples of how this might be achieved in a variety of situations.

It is important to note that the design function may apply to various facets of the operation having differing styles and time scales. Such facets are related to products, including services and software, as well as to their manufacturing processes.

Senior management needs to decide how the design function is to be managed and by whom. Senior management should also ensure that internal policies are established for design issues such as:

• assessing new product ideas
• training and retraining of design managers and design staff
• use of consultants
• evaluation of the design process
• product evaluation, including third party product certification and approvals
• patenting or other means of design protection

It is for senior management to ensure that adequate resources are available to carry out the design in the required time. This may involve reinforcing the skills and equipment available internally and/or obtaining external resources.