Download Development and Regulation of Medical Products (MEDR-101)

Development and Regulation of
Medical Products
(MEDR-101)
Prof. Moustafa M. Mohamed
Vice dean
Faculty of Allied Medical Science
Pharos University in Alexandria
• 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 13485 is an International Organization for
Standardization (ISO) standard
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
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FDA Oversight in a Medical Device Life Cycle
Research
FDA review
Design and Development
Good Clinical Practice
Clinical Trial Controls
Good Laboratory Practice
Investigational Devices
Exemptions (IDE’s)
Design Controls
Good Lab Practices
Document Controls
Electronic Records
Manufacture and Service
Quality Systems Requirements
Establishment Registration
Labeling Controls
Design controls
Recalls
Complaints
Medical Device Reporting
510(k) Clearance
Produce Marketing
Association (PMA)
Document Controls
Obsolescence
Record
Retention
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.
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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.
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Examples
Class I
Stethoscopes
Tung Depressors
Reagents used in
Clinical Labs
Powered Tooth
Brushes
Dental Chair
Class II
Catheters
Dental Implants
Biopsy Needles
Ultrasound
Imaging System
Powered
Wheelchair
Class III
Automatic
Defibrillators
Artificial Hip
Joints
Heart Valves
Extended Wear
Contact Lenses
Left Ventricular
Assist Devices
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