1. Introduction to FDA andQuality System Regulations
Quality System Regulations Training Module 1

2. Learning Objectives
Gain an understanding of the history of the Food and Drug Administration
Overview of the Quality System Regulation
3. Origins of FDA
1798
Public Health Service
1820
United States Pharmacopeia (USP)
First compendium of standard drugs
1862
US Department of Agriculture
Group of chemists form the beginnings of what becomes FDA
4. Early Regulation
1848 Drug Importation Act
Customs can stop adulterated drugs
What is adulterated?
1880 Congress Defeats Food & Drug Bill
5. Adulteration
adulterant (-dltr-nt) n. An additive causing an undesirable effect; impurity.
TITLE 21--FOOD AND DRUGS CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V--DRUGS AND DEVICES Part A--Drugs and Devices Sec. 351. Adulterated drugs and devices
6. 1906
7. Government Acts
Outrage over our food source
Harvey Wiley MD
Conducted experiments to show food can make people sick
Became first commissioner of FDA
1906 Pure Food and Drug Act
Requires labeling on foods
8. Establishment of FDA
Calls for stronger enforcement continues
FDA is created in 1930
Federal Food, Drug and Cosmetic Act passed in 1938
Creates broader definition of drug adulteration
New drugs require approval!!
Requires reports of all investigations
9. Medical Devices
1976 Medical Device Amendment
Classify devices
FDA authority to conduct appropriate level of review
Pre-amendment devices grandfathered
New devices
Premarket approval- PMA
Premarket notification-510(k)
10. Class I Medical Devices General Controls
Minimal potential for harm
Only general controls are required
Most are exempt from design controls, but not good manufacturing practices.
Notification to FDA is required in theform of registration, proper labeling
Some Class I devices do require a 510(k)
Include bedpans, exam gloves, tongue depressors
11. Class II Medical Devices General and Special Controls
General controls alone are not sufficient to assure safety and effectiveness
Special controls may include special labeling requirements, mandatory performance standards, and postmarketsurveillance
12. Class II Medical Devices General and Special Controls
Perform as indicated and will not cause injury or harm to patient or user
Devices include X-Ray machines, catheters, wheelchairs, sutures, cervical plates, pedicle screws or Intervertebral Body Fusion Implants and Instruments
13. Class III Medical Devices General Controls and PMA
Insufficient information exists to assure safety and effectiveness solely through the general or special controls
These devices need premarket approval and a scientific review to ensure the device's safety and effectiveness
Devices include heart valves, silicone-filled breast implants, pacemakers
14. Good Manufacturing Practices Regulation - 1978
Defined the minimum good manufacturing practices for processing, packing, or holding drug products and medical devices
Organization and personnel
Buildings
Equipment
Control of components
Production and process controls
Packaging and labeling
Holding distribution and installation
Device evaluation
Records
15. Safe Medical Devices Act - 1990
Strengthens the Medical Device Amendment Act
Followed the device failures of the 1980s
Mechanical heart valves
Broadens device reporting requirements for device related adverse events
Gives FDA authority over pre-production design controls
16. Quality System Regulation - 1996
Refines the GMPs and
Revised definition of becomes aware of.
Emphasis on Design Controls
17. FDA Today
Agency regulates products accounting for over 25% of American spending
Staff of over 10,000 employees
Inspect over 16,000 facilities per year
Budget of 2.1 billion (2008)
18. What the QSRs Mean to You
What is required to comply with the FDA QSR?
What does this mean for each employee?
19. Elements of 21 CFR 820
Quality System
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part
20. Elements of 21 CFR 820
Management Responsibility
Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization
21. Elements of 21 CFR 820
Quality Audit
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
22. Elements of 21 CFR 820
Personnel
Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
23. Elements of 21 CFR 820
Document Controls
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

Document approval and distribution

24. Document changes