BME416-DesignCon+Risk

BME416-DesignCon+Risk - The Regulation of Medical Device...

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Unformatted text preview: The Regulation of Medical Device Design Gerald E. Loeb, M.D. Director of the Medical Device Development Facility University of Southern California GMP Subpart C. Design Controls • Proposed Nov. 23, 1993 • Finalized Oct. 7, 1996 • Design Control Guidance March 11, 1997 – US FDA www.fda.gov/cdrh/comp/designgd.html#_Toc382720785 • Learning Year June, 1997-May, 1998 • Effective June 1, 1998 • Design Control Guidance June 29, 1999 – Global Harmonization Task Force GHTH.SG3.N99-9 • Guide to Inspections August, 1999 Design Control Regulation 820.30 (effective June 1, 1998) (a) Scope (b) Planning (c) Input (d) Output (e) Review (f) Verification (g) Validation (h) Transfer (i) Change (j) History file Document Control Regulation 820.40 (effective June 1, 1997) (a) Approval & distribution – Designated individual – Review and approve – Sign and date – Availability – Obsolescence (b) Changes – Designated individual – Review and approve – Record of changes – Communication – Effective date (a) Scope • All Class III • All Class II • Certain Class I – Computer automated – Radionuclide – Tracheobronchial suction catheter – Surgeon’s glove – Protective restraint Exclusion of “concept phase” (b) Planning • Who is responsible for the design process? • Who provides the design inputs? • How do they interface with the design team? (c) Design Input • Statement of requirements that meet the needs of patients and clinicians in the intended use. sometimes perverted into “Requirements Specification” (d) Design Output • Procedural control “procedures for defining and documenting…in terms…of conformance to design input requirements.” • Acceptance criteria for essential aspects. • No specific content given Typical Design Outputs • Complete specifications • Functional model • Manufacturing information – Schematics – Bill of materials – Component drawings & specs – Assembly procedures • Packaging and labeling Device Master Record (e) Design Review • Documented reviews including – Representatives of all functions – Outside individual – Spets PQRB = Product Quality Review Board (f) Verification • Confirm that Design Output meets Design Input Requirements (g) Validation • Devices conform to user needs under defined operating conditions • Software validation • Risk Analysis (h) Design Transfer • “procedures to ensure that the device design is correctly translated into production specifications.” hand-off form personnel training (i) Design Change • “procedures for the identification, documentation, validation…, review, and approval…before… implementation.” (j) Design History File...
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This note was uploaded on 06/08/2009 for the course BME 416 taught by Professor Loeb during the Spring '08 term at USC.

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BME416-DesignCon+Risk - The Regulation of Medical Device...

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