The document discusses FDA regulations for quality system requirements regarding medical devices. It specifically discusses 21 CFR Part 820, which are the Current Good Manufacturing Practice regulations that medical device manufacturers must follow to ensure their products are safe and of high quality. The regulations address requirements for management responsibility, quality audits, personnel training, document controls, purchasing controls, product identification and traceability, production and process controls, labeling, handling, storage, distribution, installation, and servicing. Manufacturers must establish procedures and controls to meet the requirements in each of these areas.

2.  CFR is the codification of the general and permanent regulations published in
the Federal Register by the executive departments and agencies of the federal
government of the United States.
 The CFR is divided into 50 titles that represent broad areas subject to federal
regulation.

4.  21 CFR Part 820 is part of the
(CGMP) regulations.
 It ensures that all medical devices created and developed within the US market are
safe and follow satisfactory quality processes at all stages of development.
 21 CFR 820 only applies to the United States. 21 CFR 820 is the product of the
FDA.
 FDA 21 part CFR 820 - -each one focusing on a particular area
within medical device manufacturing.

5. 820.20 Management responsibility:
a) Quality policy:
 Quality policy is established by management with executive
responsibility and it should addresses the quality.
 Management shall ensure that the quality policy is
understood, implemented, and maintained at all levels of the
organization.

6. b) Organization:
• Qualified people
• Equipment (including manufacturing equipment)
• Adequate facilities
c) Management representative: Management shall Establish authority and
responsibility for:
(i) Ensuring that quality system requirements.
(ii) Reporting the performance of quality system to management.

7. d) Management review:
 Management shall review the effectiveness of the quality system.
 The dates and results of quality system reviews shall be documented.
820.22 Quality audit:
 To assure that the quality system.
 Compliance with requirements.
 Conducted by individuals- do not have direct responsibility.
 Corrective action(s), including a re-audit of deficient matters.
 The dates are recorded.
820.25 Personnel:
(a) General: Every Personnel should be trained.
(b) Training: Procedure for Training a Personnel. Personnel shall be made
aware of device defects who perform verification and validation activities.

9. 820.40 Document controls:
a) Document approval and distribution:
 To meet the requirements.
 Including the date and signature of the individual(s) approving the
document.
b) Document changes.
 Changes shall be reviewed & approved by Individual(s).
 Changes should be communicated the Appropriate Personnel
Properly.

10. 820.50 Purchasing controls:
a) Evaluation of suppliers, contractors, and consultants:
 Maintain the Quality Requirements.
 Select potential suppliers, contractors, and consultants.
 Maintain records of acceptable suppliers, contractors, and
consultants.
b) Purchasing data:
 Quality data of the purchased product should be collected.

11. 820.60 Identification:
Identifying Products at all the stages:
 Receipts
 Production
 Distribution &
 Installation
820.65 Traceability:
 Identifying with a Control Number each unit, Lot, or Batch
Number.

12. 820.70 Production and process controls:
 Develop, conduct, control, and monitor production processes.
 Maintain control procedures.
 Process Controls includes:
1. Documented instructions, standard operating procedures (SOP's), and methods.
2. Monitoring, Control of process parameters, Components, Device
characteristics.
3. Compliance with specified standards.
4. Approval of processes and process equipment.

18. 820.120 Device labelling
 Label integrity-Remain legible
 Labelling inspection- UDI, UPC etc.,
 Labelling storage- Proper Identification
 Labelling operations- Control Labelling or
Packaging Process.
 Control number- Lot or Batch Number

20. 820.140 Handling- Prevent Contamination, Deterioration etc.,
820.150 Storage- Control of Storage Areas.
820.160 Distribution-
 The name and address of the initial consignee
 The identification and quantity of devices shipped
 The date shipped
 Control number
820.170 Installation
 Distribute the instructions and procedures
 Person installing the device-Ensure the Procedure

27.  Where servicing is a specified requirement, each manufacturer shall
establish and maintain instructions and procedures for performing and verifying
that the servicing meets the specified requirements.Service reports shall be
documented and shall include:
(1) The name of the device serviced;
(2) Unique Device Identifier (UDI) or Universal Product Code (UPC), and any
other device identification(s) and control number(s);
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspection data.