Development and Regulation of Medical Products (MEDR-101)

1. Development and Regulation of Medical Products(MEDR-101) Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria

2. This course aims to introduce an introduction to the process of medical product development with emphasis on the regulations that govern the design, fabrication, and maintenance of medical products.

3. Objectives • Define medical device • Describe the classifications of devices • Describe the ways a device can get to market • Describe how medical device clinical trials differ from drug trials

4. What is a Medical Device? An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory

5. Current Good Manufacturing Practices (cGMPs) ISO 13485 is an International Organization for Standardization (ISO) standard

6. Medical Device Design Controls Introduction to the Food and Drug Administration (FDA) Definitions Classes of devices Design control overview Risk assessment Verification and Validation testing Software Quality Assurance Labeling Post design transfer issues

7. FDA Oversight in a Medical Device Life Cycle FDA review Research Design and Development • Good Clinical Practice • Clinical Trial Controls • Good Laboratory Practice • Investigational Devices Exemptions (IDE’s) • 510(k) Clearance • Produce Marketing Association (PMA) • Document Controls • Design Controls • Good Lab Practices • Document Controls • Electronic Records Manufacture and Service Obsolescence • Recalls • Complaints • Medical Device Reporting • Quality Systems Requirements • Establishment Registration • Labeling Controls • Design controls Record Retention

8. Requirements All Class II and Class III devices, and some Class I devices require design controls. Written procedures required. Procedures are controlled via document control. Information about the design must be readily available to Food and Drug Administration FDA – Design History Files. Design controls can continue through the manufacturing and service phase.

9. Intended use Product Class • Class I-Simple, Low risk. • General controls needed (registration, labeling, GMP) • Class II- More complex, Medium risk. • Need approval (some exemptions ) • Class III- Complex, High risk. • Generally life support, life sustaining, preventing impairment to human health or unreasonable risk to human life. Premarket Approval (PMA) needed prior to market.

10. Examples