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

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.

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

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

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

Medical Device Design Controls 6 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

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

Requirements 8 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.

Intended use Product Class 9 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.

Examples 10