Design Control Guidance - Food and Drug Administration

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patient. Because the problem was not identified until the design was near completion, anexpensive, independent, back-up timer had to be added to monitor exposure times.THE QUALITY SYSTEM AND DESIGN CONTROLS. In addition to proceduresand work instructions necessary for the implementation of design controls, policies andprocedures may also be needed for other determinants of device quality that should beconsidered during the design process. The need for policies and procedures for thesefactors is dependent upon the types of devices manufactured by a company and the risksassociated with their use. Management with executive responsibility has the responsibilityfor determining what is needed.Example of topics for which policies and procedures may be appropriate are:• risk management• device reliability• device durability• device maintainability• device serviceability• human factors engineering• software engineering• use of standards• configuration management• compliance with regulatory requirements• device evaluation (which may include third party product certification or approval)• clinical evaluations• document controls• use of consultants• use of subcontractors• use of company historical dataIntroduction 3/11/97 Page 6
SECTION A. GENERALI. REQUIREMENTS§ 820.30(a) General.(1) Each manufacturer of any class III or class II device, and the class I devices listedin paragraph (a) (2) of this section, shall establish and maintain procedures tocontrol the design of the device in order to ensure that specified designrequirements are met.(2) The following class I devices are subject to design controls:(i)(ii)Devices automated with computer software; andThe devices listed in the chart below.SectionDevice868.6810 Catheter, Tracheobronchial Suction878.4460 Glove, Surgeon’s880.6760 Restraint, Protective892.5650 System, Applicator, Radionuclide,Manual892.5740 Source, Radionuclide TeletherapyII. DEFINITIONS§ 820.3 (n) Management with executive responsibility means those senior employees of amanufacturer who have the authority to establish or make changes to the manufacturer’squality policy and quality system.§ 820.3 (s) Quality means the totality of features and characteristics that bear on theability 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.Section A General 3/11/97 Page 7
Page 1: Center for Devices and Radiological
Page 5 and 6: PREFACEEffective implementation of
Page 7: TABLE OF CONTENTSFOREWORD .........
Page 10 and 11: are described in comments received
Page 12 and 13: The importance of the design input
Page 16 and 17: III. DISCUSSION AND POINTS TO CONSI
Page 18 and 19: design and development team, and pr
Page 20 and 21: more likely to be made with appropr
Page 22 and 23: Unfortunately, there are a number o
Page 24 and 25: SCOPE AND LEVEL OF DETAIL. Design i
Page 26 and 27: • The environment in which the pr
Page 28 and 29: the design and development plan, an
Page 30 and 31: Section D. Design Output 3/11/97 Pa
Page 32 and 33: capabilities. The external focus is
Page 34 and 35: Qualifications. Formal design revie
Page 36 and 37: action. In other cases, the reviewe
Page 38 and 39: manufacturers are encouraged to use
Page 40 and 41: Another self-documenting verificati
Page 42 and 43: III. DISCUSSION AND POINTS TO CONSI
Page 44 and 45: Section G. Design Validation 3/11/9
Page 46 and 47: Historically, shortcomings in the p
Page 48 and 49: DOCUMENT CONTROL. The features of a
Page 50 and 51: Section I. Design Changes 3/11/97 P
Page 52 and 53: software in each machine. The contr

Design Control Guidance - Food and Drug Administration

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