Syllabus-BMED 7040-Introduction to FDA Regulatory Compliance

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					BMED 7040 Introduction to FDA Regulatory Compliance

BME Regulatory Course Outline                         Draft: 14 November 2007

   1. References
         a. US Food & Drug Administration (FDA)
         b. CDRH - Medical Device Information
         c. Device Advice
         d. Medical Device Quality Systems Manual: A Small Entity Compliance
         e. Design Control Guidance for Medical Device Manufacturers
         f. AdvaMed (Advanced Medical Technology Association)
         g. Regulatory Affairs Professional Society (RAPS)

   2. History of Food, Drug and Device Federal Legislation
         a. Food and Drug Act of 1906
         b. Establishment of Federal Food, Drug, and Cosmetic Act 1938
                  i. Congress created Food & Drug Administration (FDA)
         c. Medical Device Act of 1976
                  i. Good Manufacturing Regulations (GMP)
                 ii. Current Good Manufacturing Regulations (cGMP)
         d. Safe Medical Devices Act (SMDA) of 1990
         e. Quality System (QS) Regulations 1996
         f. Food and Drug Administration Modernization Act (FDAMA) 1997
         g. Medical Device User Fee and Modernization Act (MDUFMA) of 2002

   3. Basic Requirements
         a. Establishment Registration
         b. Annual Device Listing

   4. Device Classifications
         a. Class I
         b. Class II
         c. Class III
         d. Device Classification Codes
         e. Product Codes

   5. Regulatory Pathways
         a. 510(k)s
         b. PMAs
         c. Clearance vs. Approval

   6. Communicating and Meeting with the FDA

   7. Guidance Documents
         a. For specific product categories
         b. Human Factors

   8. Quality System Regulations (QSRs) & Key Sections for Engineers
        a. Quality Systems

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          b.   Design Controls
          c.   Process Validation
          d.   Personnel
          e.   Buildings & Environment
          f.   Equipment & Calibration
          g.   Device Master Record
          h.   Document & Change Control
          i.   Purchasing & Acceptance Activities
          j.   Labeling
          k.   Product Evaluation
          l.   Packaging
          m.   Storage, Distribution and Installation
          n.   Complaints
          o.   Servicing
          p.   Quality Systems Audits
          q.   Factory Inspections

   9. Design Controls and the Product Development Process
         a. Documentation
         b. Reviews
         c. Approvals

   10. Device Labeling
          a. Claims
          b. Product Use Instructions (PUI)
                  i. Description
                 ii. Indications for use
                iii. Contraindications
                iv. Cautions
                 v. Warnings
          c. PUI with product or on the web
          d. Advertising, Labeling, and Claims
                  i. Promotional materials
                 ii. Training materials
                iii. Sales & technical personnel statements
                iv. Website information – US and Foreign availability

   11. Sterile Medical Device Packaging
          a. Sterilization methods
          b. Materials for sterile packaging
          c. Methods & material compatibility
          d. Sterility validation
          e. Procedure trays

   12. Device Labels
          a. Required Information
          b. Use of symbols

   13. Complaint Systems
         a. Medwatch reporting system

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   14. FDA Establishment Audits
         a. FDA’s Authority
         b. Inspection procedures and norms

   15. ISO 13485 Medical Device Standards
          a. Organization and Requirements
          b. QSRs and ISO Standard Comparison

   16. Obtaining the CE Mark

Potential speakers
   1. FDA representative -
   2. FDA Panels – Dr. Barbara Boyan, Member of Orthopaedic Device Panel
   3. Regulatory Consultant –
   4. Industry Representative -

   1. Draft a 510(k) on a class II device following directions for traditional 510(k)
   2. Develop plan for a development, clinical testing, and composition of a PMA
      (Class III) device

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