Prof. Moustafa M. MohamedVice dean

Faculty of Allied Medical SciencePharos 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 deviceDescribe the classifications of devicesDescribe 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 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

FDA Oversight in a Medical Device Life Cycle

Research Design and Development

Manufacture and ServiceObsolescence

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

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

Class I Class II Class III Stethoscopes

Tung Depressors

Reagents used in Clinical Labs

Powered Tooth Brushes

Dental Chair

Catheters

Dental Implants

Biopsy Needles

Ultrasound Imaging System

Powered Wheelchair

Automatic Defibrillators

Artificial Hip Joints

Heart Valves

Extended Wear Contact Lenses

Left Ventricular Assist Devices